CN208447812U - Monitor the equipment of utensil in the device and monitoring mouth of the physiological characteristic of patient used - Google Patents
Monitor the equipment of utensil in the device and monitoring mouth of the physiological characteristic of patient used Download PDFInfo
- Publication number
- CN208447812U CN208447812U CN201720711578.7U CN201720711578U CN208447812U CN 208447812 U CN208447812 U CN 208447812U CN 201720711578 U CN201720711578 U CN 201720711578U CN 208447812 U CN208447812 U CN 208447812U
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- utensil
- patient
- mouth
- sensor
- tooth
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Classifications
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04Q—SELECTING
- H04Q2209/00—Arrangements in telecontrol or telemetry systems
- H04Q2209/40—Arrangements in telecontrol or telemetry systems using a wireless architecture
- H04Q2209/43—Arrangements in telecontrol or telemetry systems using a wireless architecture using wireless personal area networks [WPAN], e.g. 802.15, 802.15.1, 802.15.4, Bluetooth or ZigBee
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04Q—SELECTING
- H04Q2209/00—Arrangements in telecontrol or telemetry systems
- H04Q2209/50—Arrangements in telecontrol or telemetry systems using a mobile data collecting device, e.g. walk by or drive by
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Abstract
This disclosure relates to monitor the equipment of utensil in the device and monitoring mouth of the physiological characteristic of patient used.It is a kind of for monitoring the device of the physiological characteristic of patient, described device includes: utensil in mouth, in the mouth utensil be shaped to receive patient tooth and including multiple electrodes, each electrode be positioned to when utensil is worn by the patient in the mouth and the oral cavity of patient be in electrical contact；With one or more processors, one or more processor is configured as: being measured electrical impedance using the multiple electrode, and is determined the physiological characteristic based on the electrical impedance.
Description
Cross reference to related applications
This application claims (entitled " the EMBEDDED INTRAORAL SENSING FOR submitted on June 17th, 2016
PHYSIOLOGICAL MONITORING AND TREATMENT WITH AN ORAL APPLIANCE ") US provisional patent
(entitled " the ELECTRTONIC COMPLIANCE for applying for No. 62/351,516, being submitted on June 17th, 2016
INDICATOR FOR INTRAORAL APPLIANCES ") U.S. Provisional Patent Application the 62/351,391st, Yi Jiyu
(entitled " WIRELESS ELECTRONIC the COMPLIANCE INDICATOR, READER submitted on April 7th, 2017
CASE AND USER INTERFACE FOR INTRAORAL APPLIANCES ") U.S. Provisional Patent Application the 62/483rd,
No. 283 priority.
It is incorporated by reference into
All disclosures referred in this specification and patent application pass through reference and are hereby incorporated by reference in its entirety, and degree is such as
It clearly and is individually pointed out with each individually open or patent application to be incorporated by reference into.
Technical field
This application involves but be not limited to use in monitoring patient physiological characteristic device and for monitoring making for utensil in mouth
Equipment.
Background technique
Correction process, which is usually directed to, is repositioned to desired arrangement for the tooth of patient, so as to correct malocclusion and/
Or improve beautiful.In order to realize these purposes, the orthodontic appliances such as brace, shell rectifier (shell aligners) can be by
Orthodontist is applied to the tooth of patient.The utensil can be configured as to one or more tooth applied forces, so as to basis
Treatment plan realizes that desired tooth is mobile.
During the orthodontic treatment that utensil carries out can be removed using patient, doctor can be by patient come the device that abide by the regulations
Tool uses.In some cases, patient may not wear by the orthodontic appliance of doctor's defined.For exceeding recommended range
The extension removal of any reason, utensil may interrupt treatment plan and extend entire treatment phase.In the presence of for allowing to monitor mouth
The needs of the method and apparatus of the wearing and/or effect of interior utensil.This document describes the methods and dress for executing this monitoring
It sets.
Obstructive sleep apnea (hereinafter referred to as " OSA ") be it is a kind of with sleep during the upper respiratory tract it is complete or partial
Block the medical conditions being characterized.Obstruction may with during sleep in throat or around throat soft tissue and muscle (for example, soft
Palate, back, tonsillotome, uvula with it is pharyngeal) relaxation it is related.OSA breaking-out may occur repeatedly every night, and can destroy patient
Sleep cycle.The subject of chronic OSA may undergo sleep deprivation, Excessive daytime sleepiness, confirmed fatigue, headache, snoring and
Anoxic.
Existing method and device for monitoring the physiological characteristic of the patient with such as sleep disordered situation is extremely
It may be not satisfactory in few some aspects.It is intended to provide for monitoring physiological characteristic without being placed in extrabuccal sensor
System.For example, instead of sensing on patient body, being implanted into the patient or being arranged in mouth but be connected with external device (ED)
Device, it is preferred for having the sensor of autonomous operation in the oral cavity of patient.There is provided includes in the mouth of embedded mouth inner sensor
Utensil will be helpful, and allow the physiological characteristic of self monitor patient, to provide to diagnosis sleep disturbance and other mouths
Chamber and the useful data of diseases concerned with respiratory.
Utility model content
Described herein is to include the device of equipment and system particularly including utensil (for example, orthodontic appliance) and be used for
The method for monitoring orthodontic appliance, including but not limited to compliance of the monitoring patient to orthodontic treatment.Monitoring can optionally or separately
Outer includes monitoring state, the wearing for monitoring utensil, the geography/spatial position for monitoring utensil, the environment for monitoring utensil etc..Some
In embodiment, orthodontic appliance includes one or more sensors for being configured to obtain sensing data；These sensors can be with
Sensor including instruction patient compliance (for example, patient whether worn appliance).Utensil may include being operatively coupled to
Sensor and it is configured as processing sensing data to generate one or more processors of patient compliance data, from
And make it possible to carry out electronic monitoring to patient compliance with the regulation course for the treatment of of orthodontic treatment.Advantageously, the system, method of this paper
Patient compliance can be increased with equipment and improve therapeutic effect, and offer has doctor for designing and monitoring orthodontic treatment
Patient data.
The equipment used for monitoring utensil in mouth may include: utensil shell comprising multiple tooth receiving cavities；One
Or more sensor, be operatively coupled to utensil shell and be configurable to generate the sensing that uses utensil of instruction patient
Device data；And processor, it is operatively coupled to one or more sensors and is configured as processing sensor number
According to determine, whether utensil is just being worn on the tooth of patient in mouth.
Apparatus described herein and method can be configured as detection (" intelligent measurement ") rectifier in a tooth or
Placement in multiple teeth, and can be configured as and the differentiation of other similar event, such as water logging.There is also described herein permit
Perhaps with cellular phone direct communication with the method and apparatus for activating and from monitor retrieval data.
As described above, methods and apparatus described herein can usually be set with any monitoring for monitoring orthodontic appliance
It is standby to be used together or used as part of it.For example, described herein is electronics compliance indicator (ECI) device, it can
To be configured as record wearing or intend/just intending the object of wearing orthodontic appliance (such as shell rectifier) (for example, suffering from
Person) sensing data.It will be appreciated, however, that these method and apparatus are not limited to only monitor compliance and to compliance data
Operation, can be also used for any kind of data, and these monitoring devices (including ECI) also may be collectively termed as data note
Record device or embedded data logger.Therefore, bright unless the context otherwise in description provided herein and exemplary in any one
Really explanation, otherwise when description " ECI " device, which can be not limited to compliance monitoring.Therefore, it is retouched for described herein
It states, any of example, method and apparatus, term " ECI " should be understood broadly to be known as monitoring device (MA) or property
Energy monitoring device (PMA), rather than just ECI.
For example, data can store the physics on monitoring device (for example, ECI) in either one or two of in these devices
In memory, and it can be retrieved by another equipment communicated with monitoring device.It can wirelessly be retrieved, for example, making
Data are retrieved using smart phone or other handheld devices with near-field communication (NFC) and/or bluetooth (BLE) technology.Herein
What is specifically described is monitoring device (including ECI device) and the orthodontic appliance using them, including temperature and capacitive sensing
Device, CPU, NFC communication module, NFC antenna, PCB and battery.There is also described herein can enhance signal from small monitoring device
And/or it is relayed to the shell or support (holder) of the handheld device of such as smart phone；This shell or support may
Referred to as enable the rectifier shell of NFC-BLE.
The monitoring device (such as electronics compliance indicator (ECI) device) used for being configured to utensil in monitoring mouth can
To include the shell for closing power supply and observation circuit, observation circuit includes processor, memory and one or more sensors；
Removable mechanical activation between power supply and processor interrupts, and wherein mechanical activation, which interrupts to have, breaks power supply and monitoring electricity
Connection between road between power supply and observation circuit so that do not have the first position of electric current flowing and wherein in observation circuit
There is the second position of electrical connection between power supply；And the elastomer encapsulation die (elastomeric of package casing
overmold)。
Removable mechanical activation interruption may include magnetic switch, removable activation bar, pin etc..In these devices
Any one may include dental instrument (for example, rectifier, such as shell rectifier), and monitoring device (for example, ECI) can be permanent
Ground is removably coupled to the dental instrument.
In general, the size of any of monitoring device (for example, ECI device) can be suitble to or more than one tooth.Example
Such as, shell can have 2cm or smaller, 1.5cm or smaller, 1.0cm or smaller, 0.9cm or smaller, 0.8cm or smaller,
The maximum gauge of 0.7cm or smaller, 0.6cm or smaller etc..Monitoring device shell usually can be relatively thin (for example, 1.0cm or more
Small, 0.9cm or smaller, 0.8cm or smaller, 0.7cm or smaller, 0.6cm or smaller, 0.5cm or smaller, 0.4cm or smaller
Deng).In either one or two of in these devices, observation circuit can be configured for wired connection, for example, may include in shell
The external multiple data electrodes still encapsulated by elastomer encapsulation die.The device can be configured as be connected to multiple metals/
Conductive lead wire pierces through (for example, self-healing (self-healing)) encapsulation die material to contact the touching otherwise covered
Point.
There is also described herein monitoring device (such as, the electronics compliance indicators that activation is configured as utensil in monitoring mouth
Or ECI) method.For example, a kind of method may include: to interrupt the mechanical activation of monitoring device from first position to be moved to the
Two positions, the first position destroy the connection between the power supply and observation circuit of monitoring device so that power supply and observation circuit it
Between without electric current flowing, there are the electrical connections between observation circuit and power supply in the second position；It will be coupled into orthodontic appliance
Monitoring device is inserted into the oral cavity of patient；And the data from one or more sensors are recorded using monitoring device.It moves
Dynamic mechanical activation interruption may include: to operate magnetic switch by removing monitoring device from the packaging with permanent magnet；It inserts
Enter or remove activation bar；And/or insertion or removal are sold.This method can also include that monitoring device is coupled to orthodontic appliance.It inserts
Entering monitoring device may include the monitoring device that shell rectifier is coupled in insertion.Record data may include every 1 minute to often
Every the data of 30 minutes (for example, every about 10 minutes) two or more sensors of the record from monitoring device.
There is also described herein be configured as the use of utensil in monitoring mouth and provide output via removable wired connection
Monitoring device (for example, electronics compliance instruction device).Monitoring device may include: close power supply and observation circuit outer
Shell, the observation circuit include processor, memory and one or more sensors；The self-healing elastomer rubber-coating module of package casing
Tool；Multiple data electrodes encapsulate outside the shell but by elastic encapsulation die；And it is configured as monitoring device being fixed to
The attachment of orthodontic appliance.The apparatus may include orthodontic appliance (for example, shell rectifiers).Any suitable self-healing material can be used
Material, the polymeric material including electrical isolation.
There is also described herein for transform to the signal (such as NFC signal) from monitoring device can be by smart phone
The booster and/or converter of the signal received usually have the antenna of much bigger (and match bad/be difficult to match)
For receiving NFC from monitoring device equipment.For example, described herein is for that will come from correction monitoring device (such as ECI
Monitoring device) monitoring data be relayed to the near-field communication (NFC) of hand-held processor (such as smart phone) to Bluetooth communication
(BLE) signal coupler equipment.These equipment may include: shell；First antenna, the NFC being configured in shell；
Second antenna, the BLE being configured in shell；Support is configured as keeping monitoring device and first on the shell
Antenna alignment；And NFC to BLE transmission circuit, it is configured as receiving data from first antenna and sends number from the second antenna
According to.Support may include the shell at least partly formed by shell, and be configured to monitoring device (or such as rectifier
MA and dental instrument) be maintained in shell so that monitoring device is aligned with first antenna.NFC to BLE transmission circuit can be with
Including the power supply in shell.Support may include recess on the shell.First antenna may include onboard antenna or coil day
Line；For example, first antenna includes the loop checking installation antenna with gap.
While characterized as device and method include that (including NFC to NFC is logical for the example of many near-field communications (NFC)
Letter), but any of method described herein and device can be used together with other kinds of wireless communications mode, packet
Include but be not limited to, Wi-Fi, radio (RF, UHF etc.), infrared ray (IR), microwave, bluetooth (including bluetooth low energy or BLE),
Magnetic field induction (including NFC), Wimax, Zigbee, ultrasonic wave etc..Particularly, method described herein and device may include
The device converted between these different radio modes.
There is also described herein the monitoring data relayings that will come from correction monitoring device (such as electronics compliance instruction device)
To the method for hand-held processor.For example, a kind of method may include: that monitoring device and near-field communication (NFC) are arrived Bluetooth communication
First antenna alignment in the shell of (for example, BLE) signal coupler equipment；Monitoring data from monitoring device are passed through
NFC is transmitted to NFC to BLE signal coupler equipment；And by monitoring data, from NFC to BLE, signal is coupled via Bluetooth signal
Device equipment is retransmitted to hand-hold electronic equipments.This method can also include that monitoring device is inserted into NFC to BLE signal coupling
In clutch equipment, wherein NFC to BLE signal coupler equipment is configured as shell, is configured as keeping monitoring device (or MA
With the dental instrument coupled with monitoring device).This method, which can also be included in hand-hold electronic equipments, receives Bluetooth signal,
Middle hand-hold electronic equipments include smart phone.This method modifies monitoring data before can also being included in the data that retransfer.It passes
Sending monitoring data may include receiving the NFC including monitoring data in the first antenna of NFC to BLE signal coupler equipment to believe
Number；Alternatively, or in addition, the monitoring data that retransfer may include being configured via NFC to BLE signal coupler equipment
The monitoring data as blue-teeth data are transmitted for the second antenna of Bluetooth communication.
There is also described herein for monitor patient's (including respiratory tract from patient) physiological characteristic improved system,
Method and apparatus.In many examples, a kind of orthodontic appliance is provided.Orthodontic appliance includes sensing in one or more mouths
Device is embedded in the utensil shell for being shaped to receive tooth.In some embodiments, mouth inner sensor include transmitter and
Receiver.In certain embodiments, mouth inner sensor may include multiple electrodes.One or more mouthfuls of inner sensor couplings
To one or more processors.Processor is configured as determining the mouth of patient based on the measurement result from mouth inner sensor
The feature of chamber or respiratory tract.In some cases, measurement includes impedance bioelectrical measurement.In some cases, measurement result includes coming
From the oral cavity of patient or the return signal in response to the transmitting signal from transmitter of respiratory tract.Use utensil disclosed herein
The physiological characteristic of monitoring patient allows more accurately to diagnose status of patient, such as OSA.Because the symptom of the disease of such as OSA exists
Occur when patient is unconscious, thus using in mouth utensil carry out autonomous electronic monitoring can provide otherwise be difficult to obtain or
Can not obtainable patient data, consequently facilitating to the diagnosing and treating of potential situation.Monitoring system and method disclosed herein
It can be with the utensil for such as applying the mobile power of tooth or for the device of increase respiratory tract gap (clearance) in OSA treatment
The therapeutic device of tool combines.
In one aspect, it provides a kind of for monitoring the device of the physiological characteristic of patient.The device includes being shaped as
Receive utensil in the mouth of patient teeth.The utensil includes multiple electrodes.Electrode be oriented when patient wear mouth in utensil when with
The oral cavity of patient is in electrical contact.Utensil further includes being configured with electrode to measure one or more processing of electrical impedance
Device.Processor determines the physiological characteristic of patient using the electrical impedance of measurement.
On the other hand, it provides a kind of for monitoring the device of the feature in patient oral cavity or respiratory tract.The device includes
It is shaped as utensil in the mouth for receiving patient teeth, and including transmitter and receiver.Utensil can also include one or more
Multiple processors are configured to that transmitter is made to emit signal in the oral cavity of patient；In response to the hair for using receiver to carry out
Penetrate the signal that signal measurement is returned from the oral cavity of patient or respiratory tract；And based on measured signal determine patient oral cavity or
The feature of respiratory tract.
Monitoring data are relayed to hand-held from correction electronics compliance indicator (ECI) device there is also described herein a kind of
The method of processor, which comprises by first day in ECI and the shell of near-field communication (NFC) signal coupler equipment
Line alignment；The signal coupler equipment is sent from ECI by the monitoring data by NFC；And by the monitoring data
Hand-held electronic equipment is resend to from the NFC signal coupler equipment.Wherein, retransmit includes passing through Bluetooth communication
The monitoring data are resend into the hand-held electronic equipment.This method can also include being inserted into the ECI device
Into the NFC signal coupler equipment, wherein the NFC signal coupler equipment is configured as shell, the shell quilt
It is configured to keep the ECI device.This method can also include that the ECI device is inserted into the NFC signal coupler to set
In standby, wherein the NFC signal coupler equipment is configured as shell, the shell is configured to keep the ECI device
The dental instrument coupled with the ECI device.This method can also be included in the hand-held electronic equipment described in reception
Monitoring data, wherein the hand-held electronic equipment includes smart phone.This method, which can also be included in, retransmits the number
According to modifying the monitoring data before.Wherein, sending the monitoring data includes the first of the NFC signal coupler equipment
The NFC signal including the monitoring data is received on antenna.Wherein, retransmitting the monitoring data includes via the NFC
The second antenna for being configured for Bluetooth communication of signal coupler equipment sends the monitoring data with Bluetooth signal.
Monitoring data are relayed to hand-held from correction electronics compliance indicator (ECI) device there is also described herein a kind of
The method of processor, which comprises set ECI to Bluetooth communication (BLE) signal coupler in near-field communication (NFC)
First antenna alignment in standby shell；NFC to the BLE is sent from the ECI for the monitoring data by NFC to believe
Number coupler device；The monitoring data are retransmitted from NFC to the BLE signal coupler equipment with via Bluetooth signal
To hand-held electronic equipment.This method can also include that the ECI device is inserted into NFC to the BLE signal coupler to set
In standby, wherein NFC to the BLE signal coupler equipment is configured as shell, the shell is configured to keep the ECI
Device.This method can also include that the ECI device is inserted into NFC to the BLE signal coupler equipment, wherein described
NFC to BLE signal coupler equipment is configured as shell, the shell be configured to keep the ECI device and with it is described
The dental instrument of ECI device coupling.This method, which can also be included in the hand-held electronic equipment, receives the Bluetooth signal,
Wherein the hand-held electronic equipment includes smart phone.This method, which can also be included in front of retransmitting the data, to be modified
The monitoring data.Wherein, sending the monitoring data includes the first antenna in NFC to the BLE signal coupler equipment
It is upper to receive the NFC signal including the monitoring data.Wherein, retransmitting the monitoring data includes via NFC to the BLE
The second antenna for being configured for Bluetooth communication of signal coupler equipment sends the monitoring data with the blue-teeth data.
Application also describes a kind of for monitoring the device of the physiological characteristic of patient, and described device includes: utensil in mouth,
Utensil is shaped to receive the tooth of patient and including multiple electrodes in the mouth, and each electrode is positioned to the device in the mouth
When tool the is worn by the patient and oral cavity of patient is in electrical contact；With one or more processors, one or more processor
It is configured as: measuring electrical impedance using the multiple electrode, and the physiological characteristic is determined based on the electrical impedance.Its
In, the physiological characteristic includes one of the following or more: respiratory tract diameter, respiratory tract volume, resistance of respiratory tract, lung liquid
Position, soft tissue is crowded, respiratory rate, muscle activity, the ion composition of saliva or oral mucosa ion composition.Wherein, described
Physiological characteristic is related to the sleep disturbance of patient, and the sleep disturbance includes one in sleep apnea, snoring or bruxism
Kind or more.Wherein, the sleep disturbance includes sleep apnea.Wherein, utensil is configured as treatment institute in the mouth
Sleep apnea is stated, one or more processor is additionally configured to assess based on identified physiological characteristic described
Effect of the utensil when treating the sleep apnea in mouthful.Wherein, utensil is configured as monitoring sleep breathing in the mouth
Pause.Wherein, the electrical impedance includes near field impedance, and the physiological characteristic includes that soft tissue is crowded, ion group of saliva
At or oral mucosa ion composition one of or more.Wherein, the electrical impedance includes far field impedance, and the life
Reason feature includes one or more in lung liquid level or respiratory tract length.Wherein, one or more processor is matched
It is set to by measuring the electrical impedance in response to the electric signal measurement waveform sent from the electrode in the multiple electrode.Its
In, the multiple electrode include when patient wears utensil in the mouth on the left of the oral cavity of patient near first electrode and
Second electrode near on the right side of the oral cavity of patient.Wherein, the multiple electrode includes wearing utensil in the mouth in patient
When the supramaxillary first electrode positioned at the patient and epimandibular second electrode positioned at patient.Wherein, utensil packet in the mouth
It includes the first shell for being shaped to receive the tooth of the upper jaw and is shaped to receive the second shell of the tooth of the lower jaw, and
Wherein the first electrode is coupled to the first shell and the second electrode is coupled to the second shell.Wherein, described one
A or more processor is arranged in the mouth on utensil or in the mouth in utensil.Wherein, utensil includes in the mouth
Polymer shell with multiple tooth receiving cavities.
Application also describes a kind of for monitoring the device of the physiological characteristic of the respiratory tract of patient, and described device includes:
Utensil in mouthful, utensil is shaped to receive the tooth of patient and including multiple electrodes in the mouth, and each electrode is positioned to work as
The electrical contact of when utensil is worn by the patient in the mouth and oral cavity of patient；It is one or more with one or more processors
Multiple processors are configured as: far field electrical impedance are measured using the multiple electrode, and true based on the far field electrical impedance
Determine one of the following or more: respiratory tract diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level and respiratory rate.
The device of the feature in the oral cavity or respiratory tract that application also describes a kind of for monitoring patient, described device packet
Include: utensil in mouth, utensil is shaped to receive the tooth of patient and including transmitter and receiver in the mouth；And one
Or more processor, one or more processor be configured as: emit the transmitter in the oral cavity of patient
Signal measures the signal that the signal in response to being emitted is returned from the oral cavity of patient or respiratory tract using the receiver, and
The oral cavity of patient or the feature of respiratory tract are determined based on measured signal.Wherein, the feature includes one in following
A or more: respiratory tract diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level, soft tissue be crowded, respiratory rate, muscle are living
The ion composition of dynamic, saliva ion composition or oral mucosa.Wherein, the feature is related with the sleep disturbance of patient, described
Sleep disturbance includes one of sleep apnea, snoring or bruxism or more.Wherein, the signal emitted includes electricity
Energy, sound energy or mechanical energy.Wherein, the signal emitted includes electric energy, and one or more processor is also configured
To determine the oral cavity of patient or the electrical impedance of respiratory tract based on measured signal.Wherein, the signal emitted includes first
Waveform, measured signal include the second waveform, and one or more processor is additionally configured to identify described the
Variation between one waveform and second waveform.Wherein, one or more processor is disposed in device in the mouth
On tool or in the mouth in utensil.Wherein, utensil includes the polymer shell with multiple tooth receiving cavities in the mouth.
Application also describes a kind of for monitoring the equipment of utensil in mouth used, and the equipment includes: one or more
Multiple deflectable structures, one or more deflectable structure are formed together together with utensil in the mouth or are coupled to described
Utensil in mouthful, wherein when utensil is worn on the tooth of patient in the mouth, one or more deflectable structure quilt
It is configured to deflection；And sensor, the sensor, which is configurable to generate, indicates one or more deflectable structure
Deflection sensing data；And processor, the processor can be operatively coupled to the sensor and be configured
To handle the sensing data, to determine, whether utensil is being worn on the tooth of patient in the mouth.Wherein, described
Utensil includes utensil shell in mouthful, and the utensil shell includes multiple tooth receiving cavities.Wherein, one or more deflectable knot
Structure is located near the tooth receiving cavity in the multiple tooth receiving cavity, so as to when tooth is located in the tooth receiving cavity
It is deflected outward.Wherein, one or more deflectable structure is formed in the wall of the tooth receiving cavity.Wherein, when
When tooth is located in the tooth receiving cavity, one or more deflectable structure is deflected outward at least 25 μm.Wherein,
One or more deflectable structure includes deflection state when utensil is worn in the mouth and when in the mouth
Stationary state when utensil is not worn, and wherein one or more deflectable structure is being in the deflection state
When interacted with the sensor.Wherein, the sensor includes mechanical switch, and one or more deflectable structure
It is engaged when being in the deflection state with the mechanical switch.Wherein, the sensor includes optical switch, and described one
A or more deflectable structure activates the optical switch when being in the deflection state.Wherein, one or more
A deflectable structure includes cantilever, scrobicula, concave surface, fin, protruding portion or ejecting structure.The equipment further includes communication unit,
The communication unit can be operatively coupled to the sensor, and be configured as the sensing data or processed
One or more in sensing data are sent to remote equipment.Wherein, in the sensor and the mouth utensil it is integrated or
It is coupled to tooth.Wherein, the processor is integrated or coupled to tooth with utensil in the mouth.
Application also describes a kind of for monitoring the equipment of utensil in mouth used, and the equipment includes: utensil shell, institute
Stating utensil shell includes multiple tooth receiving cavities；One or more proximity sensors, one or more proximity sensor
It can be operatively coupled to the utensil shell and be configured as generating sensing data when close with mouth inner tissue；And processing
Device, the processor can be operatively coupled to one or more proximity sensor and be configured as handling the biography
Sensor data, to determine, whether utensil is being worn on the tooth of patient in the mouth.Wherein, one or more
Proximity sensor includes one or more touch sensors.Wherein, one or more touch sensor includes at least
One capacitive touch sensors, at least one described capacitive touch sensors by with enamel, gum, oral mucosa, saliva
One or more associated charge activation in liquid, cheek, lip or tongue；Or in which one or more touch
Sensor include be configured with it is one or more in enamel, gum, oral mucosa, saliva, cheek, lip or tongue
A at least one capacitive touch sensors as grounding electrode.Wherein, one or more touch sensor includes
By at least one capacitive touch sensors of patch or bacterium associated positive charge activation on the tooth with patient.Its
In, the processor is configured to the sensing data is handled, the amount of the bacterium on tooth to determine patient.Wherein,
One or more touch sensor includes at least one resistive touch sensor.Wherein, one or more
Proximity sensor includes one of the following or more: capacitance type sensor, eddy current sensor, magnetic sensor, optics pass
Sensor, photoelectric sensor, ultrasonic sensor, hall effect sensor, Infra red touch sensors or surface acoustic wave SAW, which are touched, to be passed
Sensor.Wherein, one or more proximity sensor be configured as when close to the enamel of patient, gum, oral mucosa,
Sensing data are generated when one or more in cheek, lip or tongue.Wherein, one or more proximity sensor
It integrates with utensil in the mouth, be coupled to tooth or combinations thereof.Wherein, the processor is integrated or is coupled with utensil in the mouth
To tooth.
Application also describes a kind of for monitoring the equipment of utensil in mouth used, and the equipment includes: utensil shell, institute
Stating utensil shell includes multiple tooth receiving cavities；One or more vibrating sensors, one or more vibrating sensor
It can be operatively coupled to the utensil shell and be configurable to generate a mouthful sensing data for internal vibration mode；And processing
Device, the processor can be operatively coupled to one or more vibrating sensor and be configured as handling the biography
Sensor data, to determine, whether utensil is being worn on the tooth of patient in the mouth.Wherein, one or more
Vibrating sensor includes one of the following or more: MEMS condenser microphone, accelerometer or piezoelectric transducer.Its
In, the mouth internal vibration mode is associated with one of the following or more: the tooth of patient is transmitted to via the jawbone of patient
The vibration of tooth is ground one's teeth in sleep, speech, chewing, breathing or snoring.Wherein, the processor by by the mouth internal vibration mode and suffer from
The specific mouth internal vibration mode of person is compared to determine in the mouth whether utensil is worn.Wherein, one or more
Utensil integrates, is coupled to tooth in a vibrating sensor and the mouth, or combinations thereof.Wherein, in the processor and the mouth
Utensil is integrated or coupled to tooth.
Application also describes a kind of near-field communication (NFC) signal coupler equipment, for that will come from correction monitoring device
(MA) monitoring data are relayed to handheld processor, and the equipment includes: shell；First antenna, the first antenna are matched
It sets for the NFC in the shell；Second antenna, second antenna are located in the shell；Support, the support
On the housing, the support is configured as that the monitoring device is kept to be aligned with the first antenna；And NFC coupling
Transmission circuit, the NFC coupled transfer circuit are configured as receiving data from the first antenna and send out from second antenna
Send data.Wherein, second antenna is configured for Bluetooth communication (BLE), and the wherein NFC coupled transfer circuit quilt
It is configured to receive data from the first antenna by NFC, and data is sent from second antenna by BLE.Wherein, institute
Stating monitoring device is electronics compliance indicator (ECI) device.Wherein, second antenna is greater than the first antenna, and
It is configured for and places the phone progress NFC in the housing or on the shell.Wherein, the support includes shell
Body, the shell at least partly form from the shell and are configured as the monitoring device being maintained at the shell
It is interior, so that the monitoring device is aligned with the first antenna.Wherein, the support includes shell, the shell at least portion
Ground is divided to be formed from the shell, and the dental appliance for being configured as will be coupled into the monitoring device is maintained at the shell
It is interior, so that the monitoring device is aligned with the first antenna.Further, wherein the NFC coupled transfer circuit is included in
Power supply in the shell.Wherein, the support includes the recess on the shell.Wherein, the first antenna includes plate
Carry antenna or coil antenna.Wherein, the first antenna includes loop checking installation antenna, has the ferrite magnetic including gap
Core.Wherein, second antenna is 2 times or more of the size of the first antenna.
Application also describes a kind of near-field communication (NFC) to arrive Bluetooth communication (BLE) signal coupler equipment, in the future
It is relayed to handheld processor from the monitoring data of correction electronics compliance indicator (ECI) device, the equipment includes: outer
Shell；First antenna, the first antenna are configured for the NFC in the shell；Second antenna, second antenna are matched
It sets for the BLE in the shell；Support, on the housing, the support is configured as keeping the support
The ECI device is aligned with the first antenna；And NFC, to BLE transmission circuit, the NFC to BLE transmission circuit is configured
To receive data from the first antenna and sending data from second antenna.Wherein, the support includes shell, described
Shell at least partly forms from the shell and is configured as the ECI device being maintained in the shell, so that institute
ECI device is stated to be aligned with the first antenna.Wherein, the support includes shell, and the shell is at least partly from described
Shell is formed, and the dental appliance for being configured as will be coupled into the ECI device is maintained in the shell, so that described
ECI device is aligned with the first antenna.Wherein, the NFC to BLE transmission circuit include the power supply in the shell.Its
In, the support includes recess on the housing.Wherein, the first antenna includes onboard antenna or coil antenna.
Wherein, the first antenna includes the loop checking installation antenna with gap.
It will be apparent by reading specification, claims and attached drawing, other object and feature of the disclosure.
Detailed description of the invention
The new feature of the disclosure is especially set forth in the appended claims.It will be obtained by reference to being described in detail below
To being best understood from for the feature and advantage of the disclosure, it is described in detail below and elaborates the illustrative implementation of the principle using the disclosure
Example and attached drawing, in the accompanying drawings:
Figure 1A shows the example that tooth relocates utensil.
Figure 1B -1D shows that tooth relocates the example of system.
Fig. 2 shows the methods for the orthodontic treatment for using multiple utensils.
Fig. 3 A schematically shows the example of monitoring device (being illustrated as ECI equipment).
Fig. 3 B is schematically shown is including utensil in the mouth with one or more sensors as described herein
System and utensil and/or the digital scan data of patient teeth.Analysis engine (its can be in mouth a part of utensil or with mouth
Interior utensil separation) distal information and sensor information can be integrated, and digital scan data can be used by particular sensor
Information is associated with the tooth of patient.
Fig. 4 A shows the example of utensil in the mouth including integrated monitor equipment.
Fig. 4 B is the viewgraph of cross-section of the utensil of Fig. 4 A.
Fig. 5 shows the example of the monitoring system including the first utensil and the second utensil.
Fig. 6 A shows the example of the system including utensil in mouth and the attached peripheral device being mounted on tooth.
Fig. 6 B shows the example of the system including utensil in mouth and the attached peripheral device being mounted on tooth.
Fig. 7 A and Fig. 7 B show the example of the monitoring device with deflectable structure.
Fig. 7 C shows the example of the monitoring device with deflectable structure.
Fig. 7 D shows the illustrative methods for manufacturing utensil in the mouth with deflectable structure.
Fig. 8 A shows the example of utensil in the mouth including capacitance type sensor.
Fig. 8 B shows the example for the monitoring device being integrated into mouth in utensil.
Fig. 8 C is shown in which that the major part on rectifier surface includes utensil in the mouth of capacitive touch sensors material
Example.
Fig. 8 D shows enlarged drawing, it is shown that is distributed in the capacitive touch sensors in the mouth of Fig. 8 C on the surface of utensil
Lattice.
Fig. 9 shows the example of the monitoring system of the degree of approach between the jaw for detecting patient.
Figure 10 A shows the example of the monitoring device using optical sensing.
Figure 10 B shows the example of the monitoring device using optical sensing.
Figure 10 C shows the example of the monitoring device using optical sensing.
Figure 11 A and Figure 11 B show the exemplary operation of the monitoring device using optical sensing.
Figure 11 C and Figure 11 D show the example of the monitoring device using optical sensing.
Figure 12 A and Figure 12 B show the example for the monitoring device surveyed using magnetic strength.
Figure 12 C shows the example for the monitoring device surveyed using magnetic strength.
Figure 13 A shows the example for the monitoring device surveyed using magnetic strength.
Figure 13 B shows the example for the monitoring device surveyed using magnetic strength.
Figure 13 C shows the example for the monitoring device surveyed using magnetic strength.
Figure 14 A shows the example of the monitoring device using multiple magnets.
Figure 14 B is the viewgraph of cross-section of the equipment of Figure 14 A.
Figure 15 shows the monitoring device of the power and/or pressure that are configured as in measuring mouth between utensil and patient teeth
Example.
Figure 16 A is shown between one or more attached peripheral devices being configured as in measuring mouth on utensil and patient teeth
Power and/or pressure monitoring device example.
Figure 16 B is the viewgraph of cross-section of the equipment of Figure 16 A.
Figure 16 C is configured as the example of equipment in the mouth of the mechanical impedance of measurement one or multiple teeth.
Figure 16 D is graphically illustrated at particular tooth (or rectifier part corresponding to particular tooth) at any time
The detection of the acceleration of variation.Figure 16 E is graphically illustrated is determining the identical of acceleration as shown in Figure 16 D to it
The detection of the power changed over time at tooth (or rectifier region).Device shown in such as Figure 16 C is configured to measure
Equipment can be associated with the acceleration changed over time and the power changed over time to estimate for tooth in the mouth of mechanical impedance
Mechanical impedance.
Figure 16 F shows a part of utensil in the mouth for being configured as measurement mechanical impedance.In this example, one or more
Multiple motion sensors (for example, accelerometer) may be coupled to tooth (as a part of attachment, as shown in the figure), and can
To be communicated with the electronic component (for example, memory, processor, power supply, wireless communication etc.) on utensil in mouth.The device is also
It may include mechanical actuator or can be used together with mechanical actuator with (or measurement) perturbation vibrations known to providing, and
Known power input and the output from accelerometer can be used to determine the machinery for one or multiple teeth in processor
Impedance.
Figure 17 A shows the example of the monitoring device including mass-air-flow sensor.
Figure 17 B shows the example of the monitoring device including mass-air-flow sensor.
Figure 17 C shows the example of the monitoring device including mass-air-flow sensor.
Figure 18 shows the example of the monitoring device using motion sensing.
Figure 19 shows the example for monitoring the method for utensil used in mouth.
Figure 20 A to Figure 20 D shows the illustrative methods for manufacturing utensil in the mouth with integrated monitor equipment.
Figure 21 A to Figure 21 C shows the example for manufacturing the method for utensil in the mouth with integrated monitor equipment.
Figure 22 is the exemplary simplified block diagram of data management system.
Figure 23 shows the example of monitoring device.
Figure 24 shows the example that ECI device is coupled to rectifier.
Figure 25 shows the exemplary prototype for being coupled to the ECI device of rectifier.
Figure 26, which is graphically shown using capacitance type sensor, detects when rectifier is worn and/or be immersed in by user
In fluid (for example, water).
Figure 27 A graphically shows mutual capacitance measurement；Self-capacitance measurement is graphically shown with Figure 27 B.
Figure 28 shows the example of the ECI device with a pair of of capacitance electrode.
Figure 29 A shows the enlarged drawing of the sensing electrode on ECI device.Figure 29 B-29C is shown using from the not same feeling
The capacitance signal of electrode is surveyed to distinguish the wearing of the utensil including described ECI device.
Figure 30 A shows the example of the ECI device including a pair of of guard electrode；Figure 30 B is shown when submerged in water
The complex impedance of ECI device as shown in fig. 30 a；Figure 30 C is the example of ECI device comprising positioned at the end of rectifier utensil
The capacitance sensing electrode at place.Figure 30 D-30E shows capacitance sensing electrode and is determining there is ECI device shown in such as Figure 30 A
Utensil the explanation of false positive is distinguished when being worn.
Figure 31 A- Figure 31 D, which is shown, is configurable for coupling the near-field signals (NFC) from ECI device for making
The view of a modification of the rectifier shell of the intermediate equipment of phone is output to for Bluetooth signal.Figure 31 A is that case lid is opened
When top view.Figure 31 B shows the rearview of the shell of Figure 31 A, and Figure 31 C is the side view of the shell of Figure 31 A.Figure 31 D is
The top view of the prototype of the shell shown in Figure 31 A.
Figure 32 shows an example of the system for directly sending data to from ECI smart phone.
Figure 33 A- Figure 33 C is shown using support/fixture tool to keep the antenna alignment of ECI and phone come by data
The example of the system of smart phone is directly sent to from ECI.
Figure 34 A and Figure 34 B respectively illustrate onboard antenna and read data from ECI using onboard antenna.Figure 34 B is aobvious
The optional modification of the antenna on rectifier is shown.
Figure 35 A and Figure 35 B respectively illustrate coil antenna and use a part of coil antenna as data reader
To read data from ECI.
Figure 36 A shows the signal of the circuit diagram for the NFC coupler coupled between ECI device and smart phone
Figure.Figure 36 B, which is shown in the FERRITE CORE of a part that may be used as NFC coupler shown in such as such as Figure 36 A, to be had
The example of the loop checking installation antenna in gap.Figure 36 C shows the coupling of the total system between NFC antenna.
Figure 37 A and Figure 37 B diagrammatically illustrate NFC Coupling device.
Figure 38 shows the prototype of NFC Coupling device shown in such as Figure 37 A.
Figure 39 is the exemplary circuit diagram of NFC Coupling device.
Figure 40 is user circle of the application program for that can be monitored with coordination data transformation and/or analysis and/or compliance
The example in face.
Figure 41 is the flow chart that can be the communication protocol of a part of application program.
Figure 42 is the flow chart for the coordination near-field communication between smart phone and ECI device.
Figure 43 is the flow chart for the data processing for using the application program of processing EIC data.
Figure 44 is the flow chart for schematically showing the mode of operation of ECI equipment.
Figure 45 A-45B is the communication control for showing the reception processor (for example, smart phone) communicated with ECI equipment and carrying out
The flow chart of system.
Figure 46 is the example for data handling component/manager procedure chart.
Figure 47 shows the impedance model of patients with respiratory tract.
Figure 48 A shows the variation of the patients with respiratory tract width for different Mallampati scores, and Figure 48 B is shown
The corresponding change of the resistance of respiratory tract of function as Mallampati score.
The oral cavity that Figure 49 A shows patient can be placed to measure oral cavity and exhale together with the sensor from its such as electrode
Inhale the point of the feature in road.
Figure 49 B show can place the sensor of such as electrode can bit selecting come measure the feature in oral cavity and respiratory tract
It sets.
Figure 50 A shows the wearable utensil on patient teeth comprising is located in patient oral cavity and is diametrically opposed to one another
Point at sensor.
Figure 50 B shows the wearable utensil on patient teeth comprising the sensor of positioning close to each other.
Figure 50 C shows the inside of the utensil with embedded measurement system, which includes driving electricity
Sub- device and sensor.
Figure 50 D shows the example of the optional expanding location for sensor and driving electronic device.
Figure 50 E shows the utensil of the lower casing of the lower teeth including the upper casing and suitable patient that are suitble to the upper teeth of patient,
Each shell includes sensor.
Figure 50 F shows the utensil for being configured as measuring the impedance between the electrode on opposite sides of utensil shell.
Figure 50 G shows the utensil on upper casing and lower casing with respective sensor, wherein couples to sensor sensing.
Figure 51 A shows the block diagram of the signal chains for carrying out impedance measurement using utensil disclosed herein.
Figure 51 B shows the multiple electrodes of the impedance of the system including oral cavity or respiratory tract for measuring such as patient
The schematic diagram of oral appliance.
Figure 52 shows using utensil disclosed herein the method for monitoring the physiological characteristic of patient.
The method that Figure 53 shows the oral cavity for monitoring patient or the feature of respiratory tract.
Figure 54 shows the method that manufacture includes the utensil of sensor and control electronic device.
Figure 55 A-55C shows the exemplary rotation collected using the gyroscope accelerometer for the maxilla for being coupled to patient
Speed data.
Specific embodiment
Monitoring device described herein usually may include electronics compliance indicator (ECI).ECI can recorde from pendant
Wear the sensing data of the object of one or more dental instruments (such as dentistry/orthodontic appliance, including shell rectifier).By
The data of ECI record can store in the physical storage on ECI, and can be retrieved by another equipment.Particularly, institute
The data of description can be retrieved by the handheld electronic communication device of smart phone, tablet computer etc..Hand-hold electronic equipments can
To include the user interface for enhancing the communication between ECI and equipment, and can be to user (for example, patient) and/or skill
Art personnel, doctor, dentist, orthodontist or other medical treatment/dentist provide feedback.Once being sent to handheld device, number
According to (or being further processed) processed and/or teleprocessing unit, memory and/or server can be transmitted to.
Particularly, it is described herein be for monitoring the device including ECI, it is very small and therefore use relay,
Such as it is configured as the apparatus shell or support as relay operation.For example, described herein is logical using NFC and BLE
Letter transmits the device of data between ECI and hand-hold electronic equipments (for example, smart phone).It can be with using NFC and BLE technology
Smart phone is allowed even to fetch number from the very small ECI only including miniature antenna with quite high accuracy rate and low-power
According to.
Be described herein for monitoring can be generated using the device and method that utensil in removable mouth is treated
Relevant sensing data is used to utensil in mouth.Sensing data can be handled and be analyzed, to determine that patient is
The no treatment plan worn appliance according to regulation.Advantageously, apparatus described herein and method offer can generate more reliable
With the integrated electronics of accurate patient compliance data sensing and record (logging) system, can be used for by treatment doctor with
Track patient behavior simultaneously improves therapeutic effect.In addition, monitoring device described herein can provide the high price for utensil design
The sensing data of value.In some embodiments, the sensing data provided by monitoring device described herein may be used as feeding back,
To modify the parameter of ongoing orthodontic treatment, also referred to as self-adapting closed loop treatment plan.
ECI device as described herein can be used to be come including one or more any method appropriate as described herein
When detection device is worn on the tooth of subject.For example, the device used for monitoring utensil in mouth (ECI) can wrap
Include one or more deflectable structures that utensil in mouth is formed together or be coupled to utensil in mouth.Utensil is worn in very moment
When on the tooth of patient, deflectable structure can be shaped to deflect.The equipment may include be configurable to generate instruction can be inclined
The sensor of the sensing data of the deflection of rotation structure.Optionally, equipment may include be operatively coupled to sensor and
It is configured as the processor of processing sensing data, whether apparatus is being worn in mouth to determine.
Utensil may include utensil shell in mouthful comprising multiple tooth receiving cavities.Deflectable structure can be located at multiple teeth
Near the tooth receiving cavity of tooth receiving cavity, to be deflected outward when tooth is located in tooth receiving cavity.Deflectable structure can
To be formed in the wall of tooth receiving cavity.When tooth is located in tooth receiving cavity, deflectable structure can be deflected outward at least
25μm。
Deflectable structure may include in deflection state and very moment when utensil is worn in very moment utensil do not worn
When stationary state, and deflectable structure is interacted with sensor when being in deflection state.Sensor may include that machinery is opened
It closes, and deflectable structure can be switched when being in deflection state with engagement mechanical.Sensor may include optical switch, and
Deflectable structure can activate optical switch when being in deflection state.
Deflectable structure may include cantilever, scrobicula, concave surface, fin, protruding portion or ejecting structure.
The device, which may also include, to be operatively coupled to sensor and is configured as one or more sensing datas
Or processed sensing data is transmitted to the communication unit of remote equipment.Sensor can be integrated or coupled to utensil in mouth
Tooth.Processor can be integrated or coupled to tooth with utensil in mouth.Optionally or additionally, processor can be located at the mouth of patient
Outside chamber.
Any of the equipment used for monitoring utensil in mouth may include utensil shell comprising multiple teeth connect
It receives chamber and one or more proximity sensors, the proximity sensor is operatively coupled to utensil shell and is configured as working as
Sensing data is generated when close with mouth inner tissue.The equipment may include being operatively coupled to one or more close biographies
Sensor is simultaneously configured as the processor of processing sensing data, to determine whether utensil in mouth is worn on the tooth of patient
On.
One or more proximity sensors may include that one or more touch sensors (similarly, are retouched here
The touch bed sensor stated can be referred to as proximity sensor and/or close/touch sensor).One or more touch sensings
Device may include by associated with one of enamel, gums, oral mucosa, saliva, cheek, lip or tongue or more
Charge activation at least one capacitive touch sensors.One or more touch sensors may include by with patient
The associated positive charge of patch or bacterium on tooth is come at least one capacitive touch sensors for activating.Processor can
Selection of land is configured as processing sensing data, to determine the amount of the bacterium on patient teeth.One or more touch sensings
Device may include at least one resistive touch sensor.
One or more touch sensors may include at least one capacitance type sensor, be configured to using tooth enamel
One of matter, gum, oral mucosa, saliva, cheek, lip or tongue or more are used as grounding electrode.
One or more proximity sensors may include one of the following or more: capacitance type sensor, vortex
Sensor, Magnetic Sensor, optical sensor, photoelectric sensor, ultrasonic sensor, hall effect sensor, infrared touch sensing
Device or surface acoustic wave (SAW) touch sensor.One or more proximity sensors can be configured as when the tooth close to patient
Sensing data are generated when one or more in enamel, gum, oral mucosa, cheek, lip or tongue.It is one or more
Proximity sensor can integrate with utensil in mouth, be coupled to tooth or combinations thereof.
Processor can be integrated or coupled to tooth with utensil in mouth.
The device used for monitoring utensil in mouth may include utensil shell comprising multiple tooth receiving cavities and one
Or more vibrating sensor, be operatively coupled to utensil shell and be configurable to generate the sensor number of mouthful internal vibration mode
According to.The equipment can also include processor, be operatively coupled to one or more vibrating sensors and be configured as
Handling sensing data, whether utensil is worn on patient teeth in mouth to determine.One or more vibrating sensor packets
Include one of the following or more: MEMS microphone, accelerometer or piezoelectric transducer.Mouthful internal vibration mode can with it is following
One of or more it is associated: be transmitted to the vibration of the tooth of patient via the jawbone of patient, grind one's teeth in sleep, speech, chew, exhale
It inhales or snores.Mouth internal vibration mode and the specific mouth internal vibration mode of patient can be by being compared to determine mouth by processor
Whether interior utensil is worn.One or more vibrating sensors can integrate with utensil in mouth, be coupled to tooth or combinations thereof.
Utensil is integrated or coupled to tooth in processor and mouth.
Various embodiments described herein can make with being worn on utensil in various types of mouths in patient oral cavity and combining
With.Utensil can be for by one or more correction devices for being repositioned to desired arrangement in patient teeth in mouthful
Tool, such as rectifier or steel wire and bracket (wire-and-bracket) utensil, such as correcting patho-occlusion.Optionally
Or in addition, in mouth utensil can be used in the tooth by patient it is one or more be maintained in current arrangement, such as protect
Holder.The other examples for being suitble to utensil in the mouth being used in combination with embodiment hereof include sleep apnea therapy equipment (example
Such as, mandibular protraction equipment or clamping plate), night backplate (night guards) (for example, for treat bruxism), tooth set (mouth
) and palatal expander guards.
The utensil with tooth receiving cavity is typically shown about Figure 1A, such as apply via elastic due to utensil
Power receives and repositioning teeth.Figure 1A, which is shown, can relocate utensil or correction by the Representative dental that patient wears
Device 100, to realize the incremental repositioning of each tooth 102 in jaw.The utensil may include weighing with reception and flexibly
The shell of the tooth receiving cavity of new definition tooth.The physical model that tooth can be used manufactures utensil or part thereof indirectly.For example,
The thin slice of physical model and suitable polymer material layer that tooth can be used forms utensil (for example, polymer utensil).
In some embodiments, physical devices are for example directly manufactured using RP technique according to the mathematical model of utensil.
It while reference has been made to include the utensil of polymer shell-type utensil, but embodiment disclosed herein is very suitable for and receives
Many utensils of tooth are used together, such as the utensil without one of polymer or shell or more.The utensil can be with
With such as such as metal, glass, reinforcing fiber, carbon fiber, composite material, enhancing composite material, aluminium, biomaterial and combinations thereof
One of many materials or more be made.The utensil can shape in many ways, for example, such as using thermoforming or
Directly manufacture (for example, 3D printing, addition manufacture).Optionally or in combination, utensil can use machining manufacture, such as with
Computer numerical control (CNC) is machined the utensil manufactured by material block.
Utensil may be mounted on all teeth present in the upper jaw or lower jaw or less than all teeth.The utensil can be with
It is specially designed for accommodating the tooth of patient (for example, the topological structure of the topological structure of tooth receiving cavity and patient teeth
With), and can be manufactured based on the positive or negative model of the patient teeth by generations such as stamp, scannings.Optionally, which can
To be configured as receiving the general utensil of tooth but different figuration to match the topological structure of patient teeth.In certain situations
Under, the certain teeth only received by utensil will be relocated by utensil, and other teeth can be provided for protecting utensil
Base portion or anchorage zone in place are held, because it is to for one or the multiple teeth applied force relocated.One
In a little embodiments, certain moment during treatment, some, most of or even whole teeth will be relocated.It is moved
Dynamic tooth is also used as base portion or anchoring piece for the holder when it is worn by the patient.In general, use will not be provided
In utensil is maintained at the steel wire of appropriate location or other devices on tooth.In some situations, however, it may be desirable to or need
Individual attachment or other anchoring elements 104 are provided on tooth 102, wherein there is in utensil 100 corresponding recipient
(receptacles) or hole 106 utensil, is allowed to apply selected power to tooth.IncludingIt is used in system
Exemplary appliance in many patents and patent applications for being assigned to Align Technology company, (including for example the U.S. is special
Benefit No. 6,450,807 and No. 5,975,893) and can access on the world wide web (www (see, for example, URL
" invisalign.com ") company's site in be described.Attachment suitable for the tooth installation being used together with orthodontic appliance
Example also be assigned to Align Technology company patents and patent applications (including such as U.S. Patent No. 6,309,
No. 215 and No. 6,830,450) it is described.
Figure 1B -1D shows the example that the tooth including multiple utensils 112,114,116 relocates system 110.Herein
Any one of described utensil can be designed and/or be provided as used in the tooth repositioning system more than one group
A part of a utensil.Each utensil may be configured so that tooth receiving cavity has to correspond to and be intended in the utensil
Between or final teeth arrangement geometry.The tooth of patient can be by placing a series of incremental positions on the tooth of patient
Utensil is adjusted, is incremented by from initial teeth arrangement and is repositioned onto target tooth arrangement.For example, tooth repositioning system 110 can
To include corresponding to the first utensil 112 of initial teeth arrangement, corresponding to the one or more of one or more intermediate arrangements
A intermediate device 114 and final utensil 116 corresponding to target array.Target tooth arrangement can be in the planned correction of institute
The final teeth arrangement of the plan selected when treatment end for the tooth of patient.Optionally, target array can be controls in correction
It may include a variety of different therapeutic schemes for one of some intermediate arrangements of patient teeth during treatment process, including but
It is not limited to reduce (IPR) between the case where wherein recommending operation, wherein neighbour to be appropriate situation, the feelings for wherein arranging follow-up
The best situation of condition, wherein anchorage point wherein needs the case where carrying out palate expansion, is directed to prosthetic dentistry (for example, edge
Embedding, patch, hat, bridge, implantation material, veneer etc.) the case where etc..It will thus be appreciated that target tooth arrangement can be and follow one
Or more be incremented by the repositioning stage patient teeth any plan result arrangement.Similarly, initial teeth arrangement can
It is one or more incremental repositioning stages behind to be any initial arrangement for patient teeth.
The various embodiments of orthodontic appliance proposed in this paper can manufacture in a wide variety of ways.As an example, can be with
Such as produced by the thermoforming on formpiston or former using indirect fabrication technology this paper utensil (or part thereof) it is some
Embodiment.The indirect fabrication of orthodontic appliance may include generating patient with target array (for example, by rapid shaping, milling etc.)
The formpiston or former of denture, and one or more material sheets of thermoforming on mold, to generate utensil shell.Optionally or
In combination, some embodiments of the utensil of this paper can be manufactured directly, such as use rapid shaping, stereolithography, 3D printing
Deng.
The configuration of the orthodontic appliance of this paper can be determined according to the treatment plan of patient, for example, being related to continuous administration use
In the treatment plan for the multiple utensils for being incremented by repositioning teeth.Computer based treatment plan and/or utensil can be used
Manufacturing method is to promote designing and manufacturing for utensil.For example, one or more instrument assemblies described herein can borrow
Help the manufacturing equipment of computer control (for example, rapid shaping (such as 3D of computer numerical control (CNC) milling, computer control
Printing etc.)) carry out Digital Design and manufacture.The accurate of utensil manufacture can be improved in computer based method proposed in this paper
Property, flexibility and convenience.
In some embodiments, orthodontic appliance (utensil such as shown in figure 1A) is in the tooth receiving cavity of utensil and received
At one or more contact points between tooth and/or attachment, exert a force to the tooth on tooth bizet and/or
Attachment.Orthodontic tooth caused by the size of each of these power and/or its distribution on tooth surfaces can determine moves
Dynamic type.Tooth movement can be in any direction in any plane in space, and may include along one or more
The rotation of multiple axis is one or more in translation.As discussed further herein, the mobile type of tooth includes
It squeezes, invade, rotating, tumbling, translating and root is mobile and combinations thereof.The mobile movement for being greater than root of the tooth of bizet can claim
To tumble.The equivalent movement of bizet and root is properly termed as translating.It is mobile that the movement that root is greater than bizet is properly termed as root.
Fig. 2 shows the methods 200 of the orthodontic treatment according to the embodiment using multiple utensils.Method 200 can be used
Any of utensil as described herein or set of instruments are implemented.In step 210, the first orthodontic appliance is applied to patient's
On tooth, so that tooth is repositioned onto the second teeth arrangement from the first teeth arrangement.In a step 220, by the second correction
In appliance applications to the tooth of patient, so that tooth is repositioned onto third teeth arrangement from the second teeth arrangement.Method 200
It can according to need using any suitable quantity of continuous utensil and combination and repeat, to arrange the tooth of patient from initial
Column are incrementally repositioned onto target array.Utensil can at identical stage or time, with group or batch (for example, treating
One or more stages beginning) all generate, or generate one at a time, and can to wear each utensil straight by patient
It cannot be felt again to pressure of each utensil to tooth, or until having reached the represented tooth for giving the stage
Mobile maximum.Multiple and different utensils (for example, one group) can before patient wears any of multiple utensils quilt
It designs and is even manufactured.After worn appliance reasonable time section, patient can be replaced with next utensil in a series of
Current utensil is changed, until there is no utensil residues.Utensil is usually not fixed on tooth, and patient can be in the surgical procedure phase
Between any time at place and alternate method of packing (for example, utensil that patient can be removed).Final utensil or several in the series
Utensil can have the geometry for being selected for exaggerated correction teeth arrangement or multiple geometries.For example, one or more
It is more than the teeth arrangement for having been chosen to " final " that multiple utensils, which can have (if fully achieving) mobile independent tooth,
Geometry.In order to offset potential recurrence after re-positioning method has terminated (for example, individual tooth is allowed to return to
Its position corrected in advance), it may be necessary to this exaggerated correction.Exaggerated correction may also help speed up correcting rate (for example,
It can be with bigger rate by single tooth with the utensil for being located at the geometry beyond desired middle position or final position
Tooth shifts to the position).In such a case, it is possible to terminate appliance before tooth reaches position defined by utensil.This
Outside, exaggerated correction may be applied, deliberately to compensate any inaccuracy or limitation of utensil.
Utensil can be operatively coupled to monitoring device (also referred herein as " electronics compliance indicator ") in mouthful, should
Monitoring device is configured to supply data relevant to utensil use and/or patient compliance, and whether such as instruction utensil is worn
It wears, the time quantum that utensil is worn and/or the interaction between utensil and oral cavity are (for example, between utensil and mouth inner tissue
Contact, utensil counterpart inner tissue apply power and/or pressure) data.Optionally or in combination, monitoring device can be matched
The oral cavity that instruction patient is provided or part of it are set to (for example, tooth, gum, palate, lip, tongue, cheek, saliva, breathing
Road) one or more features data, such as temperature, color, sound, vibration, movement, pH, conductivity, charge, resistance,
Capacitor, humidity or throughput.Utensil use and/or patient compliance can be optionally determined using the feature in patient oral cavity,
As discussed in further detail herein.
Monitoring device described herein can be designed to use in the oral cavity of patient.For example, monitoring can be limited
The size of equipment is to avoid patient's discomfort and/or convenient for being integrated into mouth in utensil, as described below.In some embodiments
In, monitoring device has the height or thickness less than or equal to about 1.5mm or less than or equal to about 2mm.In some embodiments
In, monitoring device has less than or equal to about 4mm or less than or equal to about the length or width of 5mm.The shape of monitoring device can
To change as needed, such as circle, ellipse, triangle, square, rectangle etc..For example, in some embodiments, monitoring
Equipment can have circular shape of the diameter less than or equal to about 5mm.
Relatively thin and flexible monitoring device can be used to provide bigger surface area, while reducing patient's discomfort.?
In some embodiments, the monitoring device of this paper be dimensioned to meet crown surfaces (for example, the buccal surface of corona, lingual surface and/or
Occlusal surface).It is, for example, possible to use the monitoring devices for the size for multiplying about 5mm with about 10mm to cover molar corona
The buccal surface of (molar crown).As another example, the monitoring device with the about 10mm size for multiplying about 20mm can be used for
Cover buccal surface, occlusal surface and the lingual surface of corona.Monitoring device can according to need and the bizet of single tooth or multiple teeth
Coronal contact.
Other attributes (example, volume, weight) of monitoring device can be designed to reduce patient's discomfort.For example, monitoring
The weight of equipment can be selected as being no more than will apply the level of undesirable power to following tooth.
Fig. 3 A schematically shows monitoring device 300 (for example, ECI).Monitoring device 300 can be with system as described herein
Any embodiment of system and equipment is applied in combination, and the component of monitoring device 300 is equally applicable to monitoring as described herein and sets
Standby any other embodiments.Monitoring device 300 may be implemented as including with one or more dedicated in lower component
Integrated circuit (ASIC): processor 302, memory 304, one or more sensors 306, clock 308, communication unit 310,
Antenna 312, power management unit 314 or power supply 316.Referred to herein as the processor 302 of controller is (for example, centre
Reason unit (CPU), microprocessor, field programmable gate array (FPGA), logic or state machine circuit etc.) it can be configured as and hold
Row various methods described herein.Memory 304 includes various types of memories well known by persons skilled in the art, all
As RAM (for example, SRAM, DRAM), ROM (EPROM, PROM, MROM) or mixing memory (for example, flash memory, NVRAM,
EEPROM) etc..Memory 304 can be used for storing can be by the instruction that processor 302 executes to execute method provided herein.
In addition, memory can be used for storing the sensing data obtained by sensor 306, discuss in greater detail below.
Monitoring device 300 may include any amount of sensor 306, such as one, two, three, four, five or
More sensors.In some embodiments, using multiple sensors provide redundancy with increase result data accuracy and can
By property.Some or all of sensor 306 can be same type.Some or all of sensor 306 can be difference
Type.The example of sensor type suitable for monitoring device described herein includes: touch or touch sensor (for example, electricity
Appearance formula, resistance-type), proximity sensor, audio sensor (for example, MEMS (MEMS) microphone), color sensor (example
Such as, rgb color sensor), electromagnetic sensor (such as magnetic red sensor, magnetometer), optical sensor, force snesor is (for example, base
In the resistance material of power), pressure sensor, temperature sensor, motion sensor (such as accelerometer, gyroscope), vibration pass
Sensor, piezoelectric transducer, strain gauge, pH sensor, conductivity sensor, mass-air-flow sensor, gas detection sensor, humidity
Or moisture sensor, biosensor (for example, electrocardiography transducer, bio-impedance sensor, photoplethysmographic sensor,
Electrodermal reaction sensor) or combinations thereof.In some embodiments, the sensor of this paper can be configured as in response to certain kinds
The signal (for example, optics, electrical, magnetism, machinery etc.) of type is activated and/or deactivated switch.
Sensor 306 can be located at mouth in utensil any part at, such as distal portions or nearby, middle section,
Cheek, tongue, gum portion, occlusion portion or combinations thereof.When utensil is worn in the mouth of patient, sensor 306 can be determined
Position near interested adjacent tissue, such as tooth, gum, maxilla, lip, tongue, cheek, respiratory tract or combinations thereof or
It is neighbouring.For example, sensor 306 can cover a part of single tooth or single tooth when utensil is worn.Optionally,
Sensor 306 can cover multiple teeth or part thereof.It is some or all of in the embodiment using multiple sensors 306
Monitoring device can be located at the different piece in utensil and/or oral cavity.Optionally, some or all of sensor 306 can be with
At the same section in utensil and/or oral cavity.
Simulated sensor data is converted into digital lattice if desired, analog-digital converter (ADC) (not shown) can be used
Formula.As described herein, processor 302 can handle the sensing data obtained by sensor 306, to determine that utensil uses
And/or patient compliance.Sensing data and/or processing result can store in memory 304.Optionally, the number of storage
According to can be associated with the timestamp generated by clock 308 (for example, real-time clock or counter).
Monitoring device 300 may include be configured as by data stored in memory (for example, sensing data and/
Or processing result) it is sent to the communication unit 310 of remote equipment.Communication unit 310 can use any suitable communication party
Method, wired or wireless communication method (for example, RFID, near-field communication, bluetooth, ZigBee, infrared ray etc.).Communication unit
310 may include the transmitter for sending data and antenna 312 to remote equipment.Optionally, communication unit 310 includes being used for
The receiver of data is received from remote equipment.In some embodiments, the communication channel that communication unit 310 uses can also be used for for
Equipment 300 is powered, such as between data transfer period or if equipment 300 passively uses.
Remote equipment can be any calculating equipment or system, such as mobile device (for example, smart phone), individual calculus
Machine, laptop computer, tablet computer, wearable device etc..Optionally, remote equipment can be a part of cloud computing system
Or it is connected to cloud computing system (" in cloud ").Remote equipment can be with patient, treatment doctor, medical doctor, researcher etc.
It is associated.In some embodiments, remote equipment is configured as handling and analyzing the data from monitoring device 300, for example, with
Just it monitors patient compliance and/or utensil to use, with for research purposes etc..
Monitoring device 300 can be powered by the power supply 316 of such as battery.In some embodiments, power supply 316 is such as
Zinc-carbon flexible battery, zinc-manganese dioxide printing flexible battery or the printing of solid film lithium phosphorus nitrogen oxides battery and/or soft
Property battery.It the use of printing and/or flexible battery is advantageous for reducing the overall dimensions of monitoring device 300 and avoiding patient's discomfort
's.For example, printed battery can be made into various shapes, and can be stacked to form three-dimensional structure, such as with
Meet utensil and/or geometric shapes of teeth.Similarly, flexible battery can be shaped as neat with the surface of utensil and/or tooth
It is flat.Optionally or in combination, other types of battery, such as supercapacitor can be used.In some embodiments, power supply
316 can use lower-wattage Energy harvesting methods (for example, thermodynamics, electrodynamics, piezoelectricity), to be monitoring device 300
Generate electric power.Optionally, power supply 316 can be for example recharged via inductance or wireless mode.In some embodiments, when
When utensil is not used by, patient can recharge power supply 316.For example, patient can remove utensil in mouth when brushing teeth, and by device
Tool is placed on induction power hub to recharge to power supply 316.
Optionally, monitoring device 300 may include being connected to the power management unit 314 of power supply 316.Power management unit
314 can be configured as control monitoring device 300 when be in active state (for example, using electric power from power supply 316) with
And when inactive equipment 300 is (for example, not using the electric power from power supply 316).In some embodiments, monitoring device 300
It is only movable during certain times, to reduce power consumption and to reduce the size of power supply 316, so that lesser monitoring be allowed to set
Standby 300.In some embodiments, monitoring device 300 include when be in active state for controlling monitoring device 300 (for example,
It is powered, monitoring utensil use) and when in a dormant state (for example, power-off, do not monitor utensil use) monitoring device 300
Activate mechanism (not shown).The discrete assembly that activation mechanism can be used as monitoring device 300 provides, or can be by processor
302, power management unit 314 or combinations thereof is realized.Activation mechanism can be used for for example by when not in use setting monitoring
The standby 300 inactive amounts to reduce the electric power as used in monitoring device 300, this can be beneficial to the size for reducing power supply 316,
And to help to reduce integral device size.
In some embodiments, monitoring device 300 is suspend mode before being delivered to patient (for example, in storage, shipment
Deng during), and be only activated when preparing and using.This method can be beneficial to save electric power expenditure.For example, monitoring device
300 component can be electrically coupled to power supply 316 in assembling, but may be at dormant state until being activated, such as pass through
External equipment, such as mobile device, personal computer, laptop computer, tablet computer, wearable device, electric power hub
Deng.External equipment can send signal to monitoring device 300, so that activation mechanism activation monitoring device 300.Show as another
Example, activation mechanism may include switch (for example, machinery, electronics, optics, magnetism etc.), so that power supply 316 is not electrically coupled to monitor
The other assemblies of equipment 300, until switch is triggered.For example, in some embodiments, switch is the tongue stayed open by magnet
Spring switch or other magnetic sensors.Magnet can be removably attached to monitoring device 300, such as be desirably integrated into use
In equipment 300 or the packaging of utensil.When monitoring device is separated with magnet (for example, by removing magnet or moving from the package
Except equipment and utensil), it closes the switch and connects power supply 316.As another example, monitoring device 300 may include such as button
Mechanical switch, be activated manually to connect power supply 316.In some embodiments, activation mechanism includes lock function,
When activating for the first time, locking switch is to keep the connection with power supply, to keep the activation of monitoring device 300.Optionally, it is used for
The switch of activation mechanism can be activated by the component (for example, the magnet for being coupled to the tooth of patient) in the oral cavity of patient, so that
Only when the utensil is worn by the patient, monitoring device 300 is only movable, and when utensil is removed from patient mouthful, it is
Inactive.Alternatively, or in combination, switch can be by the other types of signal activation of such as optical signalling.
Figure 23 shows the monitoring device 2300 with activation mechanism according to the embodiment.With it is as described herein every other
Monitoring device is the same, and monitoring device 2300 can be similar to monitoring device 300, and may include herein in regard to monitoring device
Some or all of the component of 300 descriptions.Equipment 2300 (for example, via encapsulating material 2304) is coupled to utensil in mouth
2302.Equipment 2300 may include activation mechanism 2303 comprising magnetic switch.Before the use, equipment 2300 can be removable
Except ground is coupled to magnet 2306 (for example, using adhesive tape 2308), and magnetic switch can be maintained at open position by magnet 2306
It sets, so that equipment 2300 is inactive.When utensil 2302 prepares in use, user can remove magnet 2306, thus closed magnetic
It switchs and the component of monitoring device 2300 is connected to power supply.Utensil and monitoring device can be with many not in mouth described herein
Same mode configures.In some embodiments, utensil is operatively coupled to single monitoring device in mouth as described herein.
Optionally, utensil can be operatively coupled to multiple monitoring devices in mouth, and such as at least two, three, four, five or more
Multiple monitoring devices.Some or all of monitoring device can be same type (for example, the data for collecting same type).It is optional
Ground, some or all of monitoring device can be different type (for example, collecting different types of data).Prison described herein
Any of embodiment of measurement equipment can be used in combination with the other embodiments in utensil in single mouth.
Monitoring device can be located at utensil any part at, such as distal portions or nearby, middle section, cheek,
Tongue, gum portion, occlusion portion or combinations thereof place.When utensil is worn in the patient's mouth, monitoring device can be positioned at sense
The adjacent tissue of interest, such as near or adjacent to tooth, gum, maxilla, lip, tongue, cheek, respiratory tract or combinations thereof.Example
Such as, when utensil is worn, monitoring device can cover a part of single tooth or single tooth.Optionally, monitoring device
Multiple teeth or part thereof can be covered.In the embodiment using multiple monitoring devices, some or all of monitoring device can
To be located at the different piece of utensil.Optionally, some or all of monitoring device can be located at the same section of utensil.
Monitoring device can be operatively coupled to utensil in mouth in various ways.For example, by the way that monitoring device is coupled
To a part (for example, using adhesive, fastener, locking, lamination, molding etc.) of utensil, monitoring device can be with device in mouth
Tool is physically integrated.Coupling can be the releasable coupling for allowing that monitoring device is removed from utensil, or can be and wherein monitor
Equipment is permanently fixed the permanent connection of utensil.Optionally or in combination, it by encapsulating, being embedded in, prints or with other
Mode forms monitoring device with utensil, and monitoring device can be physically integrated with utensil in mouth.In some embodiments, the utensil
Including being configured to receive the shell of patient teeth, and the monitoring device is physically integrated with shell.Monitoring device can be located at shell
On inner surface (for example, surface adjacent with received tooth), the outer surface of shell the surface of received tooth (for example, far from)
In the upper or wall of shell.Optionally, as discussed further herein, shell may include the recipient for being configured to receive monitoring device.
The illustrative methods of the utensil for manufacturing the monitoring device with physical integration will be further described herein (for example, logical
Cross some or all that the component of monitoring device is combined during the direct manufacture of utensil).
In general, any of apparatus described herein can with the tooth of mathematical model or scanning or patient and/or
Utensil is used in combination in mouthful.For example, Fig. 3 B is schematically shown including utensil in the mouth with one or more sensors
377 and utensil and/or the digital scan data of patient teeth 379 system 383.(it can be device in mouth to analysis engine 381
A part of tool is separated with utensil in mouth) distal information and sensor information can be integrated, and digital scan can be used
Data are associated with the tooth of patient by particular sensor information.
Fig. 4 A and Fig. 4 B show utensil 400 in the mouth according to the embodiment including integrated monitor equipment 402.Utensil 400
Including the shell 404 with multiple tooth receiving cavities, and monitoring device 402 is coupled to the shell 404 of adjacent teeth receiving cavity 406
External buccal surface.In the embodiment depicted, monitoring device 402 is coupled to the tooth receiving cavity 406 for molar.It should recognize
It arrives, in an alternative embodiment, monitoring device 402 may be coupled to the other parts of shell 404, such as inner surface, lingual surface, occlusion
Face, one or more tooth receiving cavities for being used for other types of tooth (for example, front tooth, canine tooth, premolar teeth) etc..Monitoring is set
Standby 402 can be shaped as the geometry for meeting corresponding apparatus portion (for example, wall of chamber 306), in order to provide lower table
Facial contour and the discomfort for reducing patient.In some embodiments, utensil 400 includes the receiving being formed on the outer surface of shell 404
Device 408, and monitoring device 402 is located in recipient.It is described below in detail and is used to form with recipient 408 and integrates
The illustrative methods of the utensil of monitoring device 402.
Monitoring device 402 may include any of the component described herein previously with respect to the monitoring device 300 of Fig. 3 A.
For example, monitoring device 402 may include sensor 410, power supply 412 (for example, battery) and/or communication unit 414 (for example, nothing
Wire antenna).It can according to need the arrangement for changing the component of monitoring device 402.In some embodiments, sensor 410 is located at
Tooth receiving cavity 406 is neighbouring.Gap can be formed in the shell 404 adjacent with sensor 410, to allow to be directly accessed institute
Received tooth.Communication unit 414 (or its component, such as antenna) can be located on the neighbouring or outer surface of recipient 408, with
Convenient for data transmission.
In some embodiments, some components of monitoring device separately can be packed and be provided with the other assemblies of equipment.
For example, monitoring device may include with one or more components of utensil physical integration in first and with second mouthful in device
Have one or more components of physical integration.For example, in first in utensil and second mouthful utensil can be worn at it is opposite
On jaw.Any of component of monitoring device (for example, component of the equipment 300 of Fig. 3 A) can be located at the device for the upper jaw
Have, for utensil of lower jaw or combinations thereof.In some embodiments, for example, in order to adapt to space limitation, adapt to power limit
And/or sensing is improved, it is beneficial on multiple utensils by the components distribution of monitoring device.In addition, in the component of monitoring device
It is some may be used as other assemblies substrates (for example, battery be used as antenna substrate).Fig. 5 is shown according to embodiment
The monitoring system 500 including the first utensil 502 and the second utensil 504.First utensil 502, which can be shaped as, receives patient's
The tooth of arcus dentalis superior, and the second utensil 504 can be shaped as the tooth for receiving the inferior dental arch of patient.System 500 can wrap
It includes and is separated into the first subelement 506 being physically integrated with the first utensil 502 and be physically integrated with the second utensil 504 second
The monitoring device of subelement 508.In some embodiments, the first subelement 506 be include the power supply subelement of power supply 510, and
And second subelement 508 be include monitoring device remaining component sensing subelement, such as power management unit 512, processing
Device (for example, CPU514), sensor 516, memory are (for example, the RAM 518 of such as SRAM or DRAM；Such as EPROM, PROM
Or the ROM of MROM；Or the mixing memory of such as EEPROM 520, flash memory or NVRAM), communication unit (for example, antenna 522)
Or any other component 524 (for example, monitoring device 300 about Fig. 3 A) described herein.First subelement 506 and
Two subelements 508 can be operatively coupled to each other via the inductive coupling between power supply 510 and power management unit 512, example
Such as when the first utensil 502 and the second utensil 504 are close to each other by the closure of patients jaw.
The configuration of Fig. 5 can according to need variation.For example, the first subelement 506 can physically collect with the second utensil 504
At, and the second subelement 508 can be physically integrated with the first utensil 502.As another example, in 506 He of the first subelement
The distribution of monitoring device component between second subelement 508 can be different from discribed embodiment.
Optionally or in combination, monitoring device may include one or more components being physically integrated with utensil in mouth
And one or more components being physically integrated with another equipment of patient's oral external.For example, external equipment can be with
It is the wearable device that is worn on another part of patient body (for example, head-wearing device, smartwatch, wearable calculating
Machine etc.).As another example, external equipment can be electric power hub, mobile device, personal computer, laptop, put down
Plate computer etc..Any of component of monitoring device (for example, component of the equipment 300 of Fig. 3 A) can be positioned in outside
In equipment.In some embodiments, monitoring device includes the antenna and communication unit being integrated into mouth in utensil, will be from trouble
The sensor data transmission in the oral cavity of person is to external equipment, and optionally from outer equipment receiving data.Outside is integrated into set
Monitoring device component in standby can provide additional function (for example, processing and/or analysis ability), and which increase utensils in mouth
The function of interior monitoring device component.Monitoring device component in mouthful in utensil can be in the case where being with or without enhancing function
Operation.
Optionally or in combination, monitoring device may include with one or more components of utensil physical integration in mouth with
And one or more components separated in the oral cavity of patient with utensil.Mouth inner assembly can be positioned such that in utensil quilt
(for example, physical contact, communication) is interacted when wearing with the integrated package in utensil.In some embodiments, mouth inner assembly couples
To a part in oral cavity, the bizet of such as patient teeth.For example, mouth inner assembly, which can be physically integrated into, is mounted on patient teeth
On attached peripheral device in.Optionally or in combination, monitoring device can perform the operation implantation for example in patient's jawbone.Monitoring device
Any of component (for example, component of the equipment 300 of Fig. 3 A) can be located in the oral cavity of patient, rather than the utensil in mouth
In.In some embodiments, utensil sum aggregate can be removed from patient mouthful independently of mouth inner assembly into component.Advantageously, the party
Method can reduce cost by allowing identical apparatus assembly to be used together with multiple and different utensils, such as when using a system
When tooth of the shell-type utensil of column to relocate patient.
Fig. 6 A shows according to the embodiment including utensil 602 in mouth and the attached peripheral device 604 being mounted on tooth 606
System 600.Utensil 602 may include shell, has the tooth receiving cavity for being shaped to receive tooth 606 and is configured to accommodate tooth
The recipient of attached peripheral device 604 on tooth 606.In some embodiments, system 600 includes having to be physically integrated into utensil
The first subelement (for example, according to any of method described herein) in 602 and it is physically integrated into attached peripheral device 604
In the second subelement monitoring device.In some embodiments, the second subelement being integrated into attached peripheral device 604 includes prison
The relatively bulky component of measurement equipment, such as power supply, memory and/or sensor.For example, attached peripheral device 604 may include electricity
Pond or other power supplys, operationally for example via inductive coupling or using electrode 608 it is direct contact and be coupled to and collected
At to the monitoring device component in utensil 602.In an alternative embodiment, the configuration can be inverted, wherein power supply is mounted on utensil
In 602 and remaining monitoring device component is located in attached peripheral device 604.When using multiple utensils, this method can be reduced
Cost, because only that power supply is replaced each new utensil.As another example, attached peripheral device 604 may include by being located at
One or more monitoring device Component drivers in utensil 602 without source sensing element.In another example, attached peripheral device
604 may include the conducting element for triggering the switch being integrated in utensil 602.
Fig. 6 B shows according to the embodiment including utensil 652 in mouth and the attached peripheral device 654 being mounted on tooth 656
System 650.Similar with utensil 600, utensil 652 may include shell, have the tooth receiving cavity for being shaped as and receiving tooth 656
With the recipient for the attached peripheral device 654 being shaped as on receiving tooth 656.In some embodiments, system 650 includes having object
The first subelement (for example, according to any of method described herein) for being integrated into utensil 652 and physically collect to reason
At the monitoring device to the second subelement in attached peripheral device 654.The first subelement in utensil 652 may include sensing target
658, and the second subelement in accessory device 654 may include one or more sensings for being configured as detection target
Device.For example, sensing target 658 can be mirror surface or opaque surface, and sensor can be photoelectric detector.As another
Example, sensing target 658 can be magnet, and sensor can be magnetometer.In another example, sensing target 658 can
To be hardware (for example, foil, coating), and sensor can be capacitance type sensor.Optionally, sensing target 658 can
To be the electrified coil for generating AC electromagnetic field, so that sensor also obtains electric power from sensing target 658.In an alternative embodiment,
The position of the first subelement and the second subelement can be overturned, so that sensing target 658 is located in attached peripheral device 654, and is passed
Sensor is located in utensil 652.
The monitoring device of the disclosure can use many different types and configuration of sensor.Below to certain exemplary prisons
The description of measurement equipment be not intended to it is restrictive, and it will be appreciated that the feature of various embodiments described herein can be with
The feature of other embodiments is used in combination.For example, monitoring device discussed below can also include the monitoring previously with respect to Fig. 3 A
Any of the component that equipment 300 describes.Single monitoring device may include sensor type described herein and sensing
Any combination of device configuration.
In some embodiments, monitoring device includes being shaped as when utensil is worn on patient teeth in very moment and sensing
The structure of device interaction.Monitoring device may include one or more deflectable structure (examples for being formed together or coupling with utensil
Such as, cantilever, scrobicula, concave surface, fin, protruding portion, ejecting structure etc.).For example, when utensil is worn, deflectable structure can be with
It is deflected outward by the tooth of patient or the attached peripheral device for being coupled to tooth.In some embodiments, monitoring device includes sensor
(for example, mechanical switch of button), electric switch, photoswitch, proximity sensor, touch sensor etc., are configured to make a living
At the sensing data (for example, whether structure deflects, deflection distance etc.) for the deflection for indicating deflectable structure.Monitoring device may be used also
With include be operatively coupled to sensor and be configured as processing sensing data so as to generate utensil use and/or comply with
The processor of property data (for example, the information whether worn about utensil).Optionally, sensor can provide about utensil and
The more complicated data (for example, power and/or pressure data) of interaction between patient teeth.In some embodiments, deflectable
Structure is in deflection state when utensil is worn, and remains static when utensil is not worn, and deflectable knot
Structure only interacts (for example, activation) when being in deflection state with sensor.
Fig. 7 A and Fig. 7 B show the monitoring device 700 according to the embodiment with deflectable structure 702.Described
Embodiment in, deflectable structure 702 is formed in the shell 704 of utensil in mouth, such as in the wall of tooth receiving cavity 706.Prison
Measurement equipment 700 may include sensor 708 (for example, button), be configured as detecting the deflection of deflectable structure 702.Work as device
When tool is not worn on the tooth of patient (Fig. 7 A), deflectable structure 702 can be at stationary state, so that sensor 708 is not
It is activated.When utensil is worn by the patient, tooth 710 (for example, first molar teeth or second molar teeth) can be displaced outwardly deflectable
Structure 702 is to activate sensing 708.It can according to need change deflection distance.For example, structure 702 can be deflected outward at least about
25 μm, at least about 30 μm, at least about 50 μm, at least about 100 μm, at least about 200 μm, at least about 300 μm of distance, or from
Distance in the range of about 25 μm to about 300 μm.Monitoring device 700 may include for storing, handling, analyze and/or send
Other components (for example, as previously discussed with respect to described in Fig. 3 A) of sensing data.
Fig. 7 C shows the monitoring device 720 according to the embodiment with deflectable structure 722.Deflectable 722 shape of structure
At in mouth in the shell of utensil, such as in the wall of tooth receiving cavity 724.Tooth receiving cavity 724 is shaped as reception and is coupled to
The tooth 726 of attached peripheral device 728.In some embodiments, attached peripheral device 728 includes when tooth 726 is received in chamber 724
The activator appliance structure 730 for deflecting deflectable structure 722.Monitoring device 720 is included in deflectable structure 722 and is nearby installed to
The sensing subelement 732 of shell.Sensing subelement 732 include by deflectable structure 722 deflection activation sensor 734 (for example,
Switch).Optionally, sensor 732 can be covered by flexible membrane.Subelement 732 can also include power supply, processor and/or this paper
Any of described any other monitoring device component (for example, embodiment about Fig. 3 A).
Fig. 7 D shows the method according to the embodiment for manufacturing utensil in the mouth with deflectable structure.In the first step
In rapid, the mold 750 of patient's denture is provided.Mold 750 can indicate the tooth of patient for example with the arrangement of current or target tooth
Tooth.In the second step, utensil 752 in mouth are formed by forming (for example, thermoforming) material on mold 750.Optionally,
Utensil 752 can be formed by directly manufacturing (for example, stereolithography, 3D printing etc.) without the use of mold 750 in mouthful.The device
Tool may include the shell with tooth receiving cavity 754, which has in the target location for deflectable structure
There are scrobicula or concave surface 756.In third step, by the wall of cutting chamber 754 to form cantilever part, the shape in utensil 752
At deflectable structure 758.Method known to those skilled in the art (such as, laser cutting or milling) can be used and carry out actuator
The cutting of tool 752.Then, other components of monitoring device may be coupled to the utensil adjacent or neighbouring with deflectable structure 758
752。
Optionally or in combination, monitoring device may include one or more proximity sensors, is configured to work as and feel
Sensing data is generated when surveying target proximity.The example of proximity sensor suitable for embodiment hereof includes capacitive sensing
Device, electric resistance sensor, inductance sensor, eddy current sensor, Magnetic Sensor, optical sensor, photoelectric sensor, supersonic sensing
Device, hall effect sensor, Infra red touch sensors or surface acoustic wave (SAW) touch sensor.Proximity sensor is in sensing mesh
It can be activated when in target certain distance.The distance can be approximately less than 1mm, or in the range of about 1mm to about 50mm.
In some embodiments, proximity sensor can be between sensor and sensing target without being activated in the case where directly contact
(for example, maximum sensing distance is greater than zero).
In some embodiments, proximity sensor (sensing distance zero) when directly contacting with sensing target is activated,
Also referred to as touch or touch sensor.The example of touch sensor include capacitive touch sensors, resistive touch sensor,
Inductance type transducer, pressure sensor and force snesor.In some embodiments, touch sensor only passes through sensor and sensing
Direct contact between target activates (for example, maximum sensing distance be zero).In proximity sensor type described herein
Some (for example, capacitance type sensors) are also possible to touch sensor, so that they pass through close to sensing target and and target
It directly contacts and is activated.
One or more proximity sensors can integrate in mouth in utensil and for whether detecting utensil close to one
A or more sensing target.Sensing target can be a mouthful inner tissue (for example, tooth, gum, maxilla, lip, tongue, cheek
Or combinations thereof).For example, proximity sensor can be positioned on the buccal surface and/or lingual surface of utensil, so as to based on the cheek with patient
And/or tongue the degree of approach and/or directly contact detect the use of utensil.As another example, one or more close
Sensor can be positioned in utensil, to detect based on the degree of approach of enamel and/or gum and/or directly contact
The use of utensil.In some embodiments, multiple proximity sensors are located at the different location of utensil, to detect and oral cavity
The degree of approach of different piece and/or directly contact.
Optionally or in combination, one or more sensing targets may be coupled to a mouthful inner tissue (for example, being integrated in tooth
On attached peripheral device in), or can be some other components (for example, metal charge) in oral cavity.Optionally or
In combination, one or more proximity sensors can be located in oral cavity (for example, being integrated in the attached peripheral device on tooth), and
And corresponding sensing target can integrate in mouth in utensil.Optionally, the upper jaw or epimandibular first device of patient are integrated in
The sensing target or be coupled to phase that proximity sensor in tool can be used for detecting in the second utensil being integrated in opposite jaw portion
Pair jaw portion a part (for example, being attached to tooth), and therefore detect patient jaw portion between the degree of approach and/or directly
Contact.
Proximity sensor can be by the capacitance type sensor of the charge activation in sensing target.Capacitance type sensor can be with
By associated with mouth inner tissue or ingredient (such as, enamel, gum, oral mucosa, saliva, cheek, lip and/or tongue)
Charge activate.For example, capacitance type sensor can be by with the patch on patient teeth or other mouthful of inner tissue and/or carefully
The associated charge of bacterium (for example, positive charge) activates.In such embodiments, capacitance sensing data can be used for determining utensil
Whether worn, and the optionally amount of the dental plaque on tooth and/or bacterium.As another example, capacitance type sensor can
To be activated by charge associated with corona, such as due to there is the negative electricity with the ionization carboxyl of sialic acid covalent bonding
Lotus.
The various configurations of capacitance type sensor can be used for monitoring device as described herein.In some embodiments, group in mouth
The charge on surface knitted may interfere with the electric field of capacitance type sensor.Optionally or in combination, mouth inner tissue may be used as electricity
The grounding electrode of capacity sensor.It is alternatively possible to boot up condenser type in specific position and/or side using shielding body
The electric field of sensor, for detecting the contact with specific organization.
Fig. 8 A shows utensil 800 in the mouth according to the embodiment including capacitance type sensor 802.In some embodiments
In, the sensing target for capacitance type sensor 802 is the surface of patient teeth 804, and capacitance type sensor 802 is coupled to
The inner surface of the tooth receiving cavity 806 of utensil in mouthful, to close on tooth 804 in worn appliance.Capacitance type sensor 802 can
It is activated and directly contacting close to tooth 804 and/or with tooth 804.In some embodiments, capacitance type sensor 802
It is activated by the negative electrical charge on the enamel of corona.Optionally or in combination, capacitance type sensor 802 can by with
The associated positive charge of patch and/or bacterium on corona activates.Optionally, capacitance type sensor 802 can by with trouble
The associated charge of the mineral in saliva on the dental surface of person activates, including but not limited to NH4+, Ca2+, PO43 ",
HCO3- and F.
Fig. 8 B shows the monitoring device 850 according to the embodiment being integrated into mouth in utensil 852.Monitoring device 850 can
To be located on any suitable part of utensil 852, the buccal surface and/or lingual surface of the adjacent teeth receiving cavity of such as utensil 852.If
Standby 850 may include capacitance type sensor 854 (for example, capacitive touch sensors grid).Capacitance type sensor 854 can be with class
It is similar to the sensor 802 described in Fig. 8 A.In some embodiments, capacitance type sensor 854 is flexible and/or can heat
It is molding, to meet the shape of utensil 852.Monitoring device 850 can also include the control for being coupled to capacitance type sensor 854
Device and power supply 856, and any other component of the description of monitoring device 300 herein in regard to Fig. 3 A.For example, controller and power supply
856 can be used for for the power supply of capacitance type sensor 854, the degree of approach and/or contact that processing is obtained by capacitance type sensor 854
Data store data and/or processing result obtained, and/or send data and/or processing result to remote equipment.
Although Fig. 8 B shows the single monitoring device 850 with single capacitance type sensor 854, other also can be used
Configuration.For example, in an alternative embodiment, monitoring device 850 may include multiple electricity at the different location on utensil 852
Capacity sensor, with detection with the degree of approach of multiple positions in oral cavity and/or contact.It is alternatively possible to use multiple monitorings
Equipment, wherein each equipment is coupled to one or more corresponding capacitance type sensors.
In some variations, utensil (is shown as rectifier, but institute as above in this example in the mouth of most of (or whole)
State, can be configured as utensil in any other mouth) it may include capacitive touch sensors material.As shown in Figure 8 C, rectify
Positive device 890 includes the formation surface of capacitive touch sensors material 893.Fig. 8 D, which is shown, can be distributed in the mouth of Fig. 8 C
The enlarged drawing of the lattice of capacitive touch sensors on the surface of utensil.
Capacitive touch sensors can be related to intensity and the position of touch information, and can export on patient teeth
The power (torque and power direction) of utensil in mouth.In some variations, utensil may include for from capacitance type sensor
Grid receives one or more processors of touch information, and the power that the information and the utensil can be applied on tooth
It is associated.For example, using patient teeth and/or the mathematical model (as usually discussed in figure 3b above) of rectifier, capacitor
Formula touch data can be associated with particular tooth.
Fig. 9 shows the monitoring system 900 of the degree of approach between the jaw portion according to the embodiment for detecting patient.System
900 include the second utensil 904 that first be worn on the upper tooth of patient utensil 902 and be worn on the lower tooth of patient.System
900 further include monitoring device comprising with the first utensil 902 integrate first sensing subelement 906 (for example, first plate), with
The second sensing subelement 908 (for example, second plate) and integrate and be coupled to the first utensil 902 that second utensil 904 integrates
The controller 910 of first sensing subelement 906.Optionally, controller 910 can be integrated with the second utensil 904 and be coupled to the
Two sensing subelements 908.In some embodiments, monitoring device is for measuring the first sensing subelement 906 and the second sensing
Capacitor and/or charge between unit 908, and measurement data can be used for determining whether the jaw portion of patient is closer to each other.
Optionally or in combination, monitoring device may include the sensor number for being configurable to generate instruction mouth internal vibration mode
According to one or more vibrating sensors.The example of vibrating sensor includes audio sensor (for example, MEMS microphone), adds
Speedometer and piezoelectric transducer.Mouthful internal vibration mode can with it is one of following or more associated: via the jaw of patient
Bone is transmitted to the vibration of the tooth of patient, grinds one's teeth in sleep, speech, chewing, breathing or snoring.In some embodiments, mouth internal vibration mould
Formula is originated from the received sound of patient's ear drum membrane.It is movable in mouth that mouthful internal vibration mode may originate from, such as grind one's teeth in sleep, speech, chewing,
Breathing, snoring etc..The sensing data generated by vibrating sensor be can handle to determine utensil use and/or patient compliance
Property.For example, monitoring device may include processor, the mouth internal vibration mode that will test and the specific mouth internal vibration mould of patient
Formula is compared, to determine whether the utensil is worn on the tooth of patient.In some embodiments, processor uses patient
The past data of specific mouth internal vibration mode is trained, then by matching mode measure come true with preceding mode
Determine whether utensil is worn.It optionally or in combination, can be by the way that the vibration mode of measurement be obtained with when utensil is not worn
The vibration mode obtained is compared to determine that utensil uses.
Optionally or in combination, monitoring device may include being configured as having one used based on optical signal detector
Or more optical sensor.For example, optical sensor can be configured as the color sensing of the color of detection mouth inner tissue
Device (for example, multichannel color sensor of single channel color sensor, such as RGB sensor).It in some embodiments, can be with
One or more color sensors are integrated into mouth in utensil, to be positioned to when utensil is worn in mouth and specific mouth
Inner tissue's (for example, enamel, gum, cheek, tongue etc.) is adjacent.The equipment can based on the color that sensor detects whether
Determine whether utensil is currently being worn with the expection color-match of tissue.In such embodiments, monitoring device can
To include providing one or more light sources (for example, LED) of illumination for color sensor.
As another example, monitoring device may include one or more transmitters for being configurable to generate optical signalling
(for example, LED) and one or more optical sensors (for example, photoelectric detector) for being configured as measurement optical signalling.Example
Such as, transmitter can be located so that when utensil is worn, optical signalling is from surface (for example, utensil in mouth inner tissue, mouth
A part) reflection, to reach corresponding optical sensor.In some embodiments, when utensil is not worn, optical signalling
It is not reflected and does not reach optical sensor.Therefore, the activation of optical sensor can indicate that the utensil is currently worn
It wears.
Figure 10 A shows the monitoring device 1000 according to the embodiment using optical sensing.Equipment 1000 includes being integrated into
Transmitter 1002 and optical sensor 1004 in mouthful in utensil 1006.In the embodiment depicted, transmitter 1002 and biography
Sensor 1004 is all located on the buccal surface of utensil 1006, so that when utensil 1006 is worn, the optical signal from transmitter 1002
It is reflected from the cheek 1008 of patient, to reach sensor 1004.In an alternative embodiment, transmitter 1002 and sensor 1004
It can be located on the lingual surface of utensil 1006, so that the optical signalling from transmitter 1002 is reflected from the tongue of patient to reach and pass
Sensor 1004.
Figure 10 B shows the monitoring device 1020 according to the embodiment using optical sensing.Equipment 1020 includes being integrated into
The transmitter 1022 and optics being worn in the first in the jaw portion (for example, the upper jaw or lower jaw) of patient in utensil 1026 pass
Sensor 1024.Transmitter 1022 and sensor 1024 can be disposed such that when 1028 quilt of the first utensil 1026 and the second utensil
When wearing, the utensil 1028 out of second mouthful in the opposite jaw portion for being worn on patient of the optical signalling from transmitter 1022 is anti-
It projects to reach sensor 1024.Optionally, the second utensil 1028 may include having to be selected for enhancing and/or control
The surface 1030 of the optical characteristics of the reflection of optical signalling.
As another example, transmitter may be oriented such that optical signalling is directly transmitted when utensil is worn
To optical sensor, without any reflection from another surface.In some embodiments, when utensil is not worn
When, optical signalling will not reach optical sensor.Therefore, the activation of optical sensor can indicate that the utensil is currently worn
It wears.
Figure 10 C shows the monitoring device 1040 according to the embodiment using optical sensing.Equipment 1040 includes being integrated into
It transmitter 1042 in the first being worn in the jaw portion (for example, the upper jaw or lower jaw) of patient in utensil 1044 and is integrated into
It is worn on the optical sensor 1046 in second mouthful in the opposite jaw portion of patient in utensil 1048.Transmitter 1042 and sensing
Device 1046 can be disposed such that the light from transmitter 1042 when the first utensil 1044 and the second utensil 1048 are worn
It learns signal and is transmitted directly to sensor 1046.In another example, transmitter may be oriented such that when utensil is worn
When optical signalling blocked by mouth inner tissue (for example, tongue of patient).In some embodiments, when utensil is not worn, light
Signal is learned not to be blocked and reach optical sensor (for example, via direct transmission or reflection from surface).Therefore, optics passes
The activation of sensor can indicate the utensil currently without being worn.Optionally, optical signalling can be infrared light, so as to patient
More unobtrusively.
Figure 11 A and Figure 11 B show the monitoring device 1100 according to the embodiment using optical sensing.Equipment 1100 includes
It is integrated into transmitter 1102 and optical sensor 1104 in mouth in utensil 1106.Transmitter 1102 and sensor 1104 can be determined
Position is on the opposite side of the lingual surface of utensil 1106, so that optical signalling is straight from transmitter 1102 when utensil 1106 is not worn
It connects and is transmitted to sensor 1104 (Figure 11 A).When utensil 1106 is worn (Figure 11 B), the tongue 1108 of patient can block hair
The transmission of optical signalling between emitter 1102 and sensor 1104.
Figure 11 C and Figure 11 D show the monitoring device 1120 according to the embodiment using optical sensing.Equipment 1120 includes
It is integrated into transmitter 1122 and optical sensor 1124 in mouth in utensil 1126.Transmitter 1122 and sensor 1124 can positions
In the same side of the lingual surface with utensil 1126, so that being generated when utensil 1126 is not worn (Figure 11 C) by transmitter 1122
Optical signalling is reflected from opposite lingual surface 1128 to reach sensor 1124.It is alternatively possible to select the optics on surface 1128
Characteristic enhances and/or controls the reflection of optical signalling.When utensil 1126 is worn (Figure 11 D), the tongue 1130 of patient can
To block the transmission of the optical signalling between transmitter 1122 and sensor 1124.
In addition, the monitoring device described herein based on optical sensing can be additionally configured to detection by breathing, chewing
Or the variation of the mobile caused optical signalling reflecting and/or transmission of other patients.The information can be used for further increasing base
In reliability and accuracy that the compliance of optical sensing monitors.
Optionally or in combination, the monitoring device of the disclosure may include being configured as the variation based on magnetic field come detector
Have one or more magnetic sensors used.The example of magnetic sensor suitable for embodiment hereof include magnetometer,
Hall effect sensor, magnetic reed switch and magnetoresistive sensor.In some embodiments, the characteristic (for example, size, direction) in magnetic field
Currently whether become by wearing based on the utensil, such as due to the interference of the mouth inner tissue from such as tooth.Therefore, the equipment
It can determine that utensil is used by handling and analyzing the magnetic field detected by magnetic sensor.
Figure 12 A and Figure 12 B show the monitoring device 1200 according to the embodiment using magnetic sensing.Equipment 1200 includes
It is coupled to the magnet 1202 and sensing subelement 1204 of utensil 1206 in mouth.For example, utensil 1206 may include connecing with tooth
The shell of chamber is received, and magnet 1202 and sensing subelement 1204 may be coupled to the outer surface of tooth receiving cavity.Sense subelement
1204 measure the one or more of the characteristic (for example, magnetic, direction) in the magnetic field generated by magnet 1202 including being configured as
Magnetic sensor 1208 (for example, three magnetometers).In some embodiments, when utensil 1206 is worn by patient, in chamber
Received tooth 1210 interferes magnetic field (Figure 12 B), so that (Figure 12 A) is different when field characteristic is not worn from utensil.Monitoring device
1200 may include being configured as determining what whether utensil was worn based on the sensing data generated by magnetic sensor 1208
Processor (not shown).
Figure 12 C shows the monitoring device 1220 according to the embodiment using magnetic sensing.Equipment 1220 includes being integrated into
Be worn in the first on patients jaw (for example, the upper jaw or lower jaw) in utensil 1224 magnetic sensor 1222 (for example,
Hall effect sensor or magnetoresistive sensor).Magnetic sensor 1222 be used for detect by be worn in opposite jaw portion second
The magnetic field that magnet 1226 in mouthful in utensil 1228 generates.In some embodiments, the characteristic in magnetic field is based on the first utensil 1224
Whether it is worn on the tooth of patient and changes with the second utensil 1228.Monitoring device 1220 may include being configured as being based on
The sensing data generated by magnetic sensor 1222 determine processor (not shown) that whether utensil is worn.
Monitoring device based on magnetism sensing may include changing the ferromagnetic target (example of magnetic signature when utensil is worn
Such as, metal plate).Ferromagnetic target is desirably integrated into mouth in utensil or the attached peripheral device being mounted on tooth, or can be mouth
Existing element (for example, metal charge, implantation material etc.) in chamber.Monitoring device can by sense magnetic field characteristic and detection
Ferromagnetic target whether there is to detect whether patient is used the utensil.
Figure 13 A shows the monitoring device 1300 according to the embodiment using magnetic sensing.Monitoring device 1300 includes collection
At to 1302 He of sensing subelement in utensil 1304 in the first in the jaw portion (for example, the upper jaw or lower jaw) for being worn on patient
It is integrated into the ferromagnetic target 1306 (for example, metal plate) in second mouthful in the opposite jaw portion for being worn on patient in utensil 1308.
Sensing subelement 1302 may include magnet 1310 and magnetic sensor 1312, which detects by magnet 1310
The magnetic field of generation.In some embodiments, when the first utensil 1304 and the second utensil 1308 are worn by the patient, ferromagnetic target
1306 presence changes the characteristic in magnetic field generated.Monitoring device 1300 may include being configured as based on by magnetic transducing
The sensing data that device 1312 generates determine processor (not shown) that whether utensil is worn.
Figure 13 B shows the monitoring device 1320 according to the embodiment using magnetic sensing.Monitoring device 1320 includes collection
At the sensing subelement in the attached peripheral device to the tooth 1324 in the jaw portion (for example, the upper jaw or lower jaw) for being coupled to patient
1322 and it is integrated into the ferromagnetic target 1326 (for example, metal plate) in the mouth being worn in opposite jaw portion in utensil 1328.It is optional
Ground can also wear utensil 1329 in second mouthful including the chamber for being shaped to receive tooth 1324 and sensing subelement 1322.
Sensing subelement 1322 may include magnet 1330 and magnetic sensor 1332, which detects by magnet 1330
The magnetic field of generation.In some embodiments, when utensil 1328 is worn by the patient, the presence change of ferromagnetic target 1326 is generated
Magnetic field characteristic.Monitoring device 1320 may include be configured as based on the sensing data generated by magnetic sensor 1332 come
Determine the processor (not shown) whether utensil 1328 is worn.Optionally, the processor and other assemblies of monitoring device 1320
It can also be integrated into attached peripheral device.This realization can reduce the cost of equipment 1320, because only that relatively low cost
Ferromagnetic target will be replaced each new utensil.Figure 13 C shows the monitoring device according to the embodiment using magnetic sensing
1340.Monitoring device 1340 includes the attached of the tooth 1344 being integrated into the jaw portion (for example, the upper jaw or lower jaw) for being coupled to patient
It connects the sensing subelement 1342 in equipment and is integrated into the ferromagnetic target in the mouth being worn in identical jaw portion in utensil 1348
1346 (for example, metal plates).Utensil 1348 may include being shaped as the chamber for receiving tooth 1344 and sensing subelement 1342.
Sensing subelement 1342 may include magnet and magnetic sensor, detect the magnetic field generated by magnet.In some embodiments,
When utensil 1348 is worn by the patient, the presence of ferromagnetic target 1346 changes the characteristic in magnetic field generated.Monitoring device 1340
It may include the processing for being configured as determining whether utensil 1348 is worn based on the sensing data generated by magnetic sensor
Device (not shown).Optionally, the processor of monitoring device 1340 and other assemblies can also be integrated into attached peripheral device, thus
Cost is reduced when using multiple utensils.
Optionally or in combination, monitoring device can be used magnet and directly activate magnetic sensor.For example, magnet can be with
It is attached to a mouthful inner tissue, such as dental surface.Monitoring device may include magnetic sensor (for example, magnetic red sensor or opening
Close), it is integrated into utensil in mouth and the magnet when utensil is worn is made to activate sensor.In an alternative embodiment, it can cut
The position of magnet and magnetic sensor is changed, so that magnetic sensor is attached to mouthful inner tissue and magnet is integrated into utensil.
Optionally, magnet is desirably integrated into the first in the jaw portion (for example, the upper jaw or lower jaw) for being worn on patient in utensil, and
Magnetic sensor can be integrated into second mouthful be worn in opposite jaw portion in utensil, so that when two utensils are worn
Magnet activates sensor.
Optionally or in combination, monitoring device can use two or more magnets interactively with each other (for example, passing through
To applying magnetic force each other) and detection magnet between interaction sensor.For example, sensor can be coupled to magnet and by
It is applied to the mechanical switch of the magnetic drive on magnet.As another example, sensor can be configured as detection by other magnetic
Body is applied to the characteristic (for example, size, direction) of the magnetic force on magnet.Magnet and sensor can be integrated in device each independently
In tool or it is coupled to tooth or other mouthfuls of inner tissues.
Figure 14 A and Figure 14 B show the monitoring device 1400 according to the embodiment using multiple magnets.Equipment 1400 includes
It is integrated in the sensing subelement in the first in the jaw portion (for example, the upper jaw or lower jaw) for being worn on patient in utensil 1404
1402.Sensing subelement includes the first magnet 1406 for being coupled to force snesor 1408.Second magnet 1410 is integrated into wearing
In second mouthful in opposite jaw portion in utensil 1412.Force snesor 1408 can be measured in the first magnet 1406 and the second magnetic
Magnetic force between body 1410, the magnetic force change according to the distance between magnet.Monitoring device 1400 may include being configured as
The processor (not shown) whether utensil is worn is determined based on the power of measurement.In some embodiments, magnetic force can also be used for
Generate the electric power for being used for monitoring device 1400.
Optionally or in combination, the monitoring device of the disclosure may include for detect utensil use it is one or more
Power and/or pressure sensor.For example, monitoring device may include dependent on power and/or the resistance material dependent on pressure, such as
Film or piece.Resistance material can be located between two thin electrodes in mouth in utensil, and when power and/or pressure for example pass through tooth
Interaction between tooth and utensil and when being applied on material, the resistance of material can increased or decrease.Other kinds of power
And/or pressure sensor includes strain gauge and piezocrystal sensor.In some embodiments, monitoring device is based on by power
And/or whether the power that obtains of pressure sensor and/or pressure measuring value determine the patient just in worn appliance.Measurement data can be with
Indicate the power and/or pressure between utensil and one or more mouth inner tissues of such as patient teeth.Optionally, number is measured
According to can be based on utensil and the power and/or pressure that are mounted between one or more attached peripheral devices on patient teeth.Monitoring
Equipment can handle data to determine the power measured and/or pressure whether in desired extent corresponding with the patient of worn appliance
It is interior.
Monitoring device may include single power and/or pressure sensor or multiple power and/or pressure sensor.Sensor
It can be positioned at any position in utensil, such as inner surface, outer surface, buccal surface, lingual surface, occlusal surface, middle section, distal end
Partially, gum portion or combinations thereof.In some embodiments, when utensil is worn, sensor is positioned close to certain teeth
Tooth.In the embodiment that utensil is orthodontic appliance, sensor be can be positioned near tooth to be relocated, such as wherein
Utensil is expected the position to tooth applied force.For example, if utensil is shaped as the attached peripheral device that engagement is mounted on tooth
So as to tooth applied force, then power and/or pressure sensor can joint place between utensil and attached peripheral device or
Near.
Figure 15 show the power according to the embodiment being configured as in measuring mouth between utensil 1502 and patient teeth and/or
The monitoring device 1500 of pressure.Equipment 1500 includes being electrically coupled (for example, via track 1505 or other connecting elements) to control
The multiple pressure and/or force snesor 1504 (for example, the resistive film for depending on pressure) of device 1506 processed.Multiple pressure and/or power
Sensor 1504 can be patterned on the inner surface of utensil 1502, so as to generate instruction utensil 1502 and patient teeth it
Between pressure and/or power sensing data.In some embodiments, utensil 1502 includes multiple tooth receiving cavities, and is pressed
Power and/or force snesor 1504 are located on the buccal surface, lingual surface and/or occlusal surface of chamber.Controller 1506 may include being configured as
The component (for example, as previously discussed with respect to described in Fig. 3) that sensing data is handled to determine whether utensil 1502 is worn.It is optional
Ground, controller 1506 may include being sent to the wireless antenna 1508 of remote equipment for that will sense data and/or processing result,
As described herein.
Figure 16 A and Figure 16 B, which are shown, according to the embodiment is configured as utensil 1602 and patient teeth 1606 in measuring mouth
On one or more attached peripheral devices 1604 between power and/or pressure monitoring device 1600.Equipment 1600 includes thermocouple
Close the multiple pressure and/or force snesor 1608 (for example, the resistive film for depending on pressure) of controller 1610.Multiple pressure
And/or force snesor 1608 can be patterned on the inner surface of utensil 1602, to generate instruction utensil 1602 and patient
The sensing data of the pressure and/or power between attached peripheral device 1604 on tooth 1606.In some embodiments, utensil
1602 include the multiple tooth receiving cavities for being formed with one or more recipients 1612, to receive the correspondence on patient teeth
Attached peripheral device 1604, and pressure sensor and/or force snesor 1608 can be positioned at one or more recipients
1612 inner surface.Controller 1610 may include being configured as processing sensing data to determine whether utensil 1602 is worn
Component (for example, as previously discussed with respect to described in Fig. 3 A).
Any of device described herein (for example, monitoring device) can be configured as in determining tooth and/or mouth
The mechanical impedance of utensil.For example, any of device described herein can be configured as export tooth, multiple or one group of tooth
The mechanical impedance of tooth and/or utensil.In general, mechanical impedance can show the resistance of motion of the power applied out:
Z (w)=F (w)/v (w)
Wherein, F=power, v=speed and w=angular frequency.
Figure 16 C is shown by including motion sensor 971 (such as accelerometer) and one or more force snesors
969,969', 969 " mouth in utensil 977 (being shown as rectifier in this example) section an example.Optionally or separately
Other places, one or more in motion sensor and force snesor can be positioned directly on tooth that (including being suitable for will be in mouth
Utensil is fixed on the attachment on tooth), and can be with processor/analysis engine, battery, the telecommunication circuit etc. on rectifier
It is communicated.
Then, processor/analysis engine can be used movement (for example, acceleration) data with time change (it show
Example is shown in Figure 16 D) and the corresponding force data (its example is shown in Figure 16 E) that changes over time, and can close
Join the data to estimate mechanical impedance.
Alternatively, or in addition, system can be based on underdamping second-order system estimation mechanical impedance (for example, as underdamping
The logarithmic decrement of second-order system).In this case, which may be configured to measure to the tooth of perturbed force (and/or device
Tool) it responds, which is such as applied to the inputted vibration or power of tooth.For example, the device may be configured to measurement to machine
The free vibration of tool pulse input responds.Then the device can determine the week of the peak to peak decaying and system of underdamped oscillation
Phase；According to these values, then which can export damped natural frequency, intrinsic frequency and damping ratio.In second-order system, these
Value can define impedance.
For linear system, which can be by the parameter fitting of the parameter model of mechanical impedance to the Bode diagram of measurement.
For nonlinear system, which can be used generalized frequency response functions to analyze nonlinear system (for example, forced vibration is rung
Answer, sinusoidal frequency scanning etc., including machine learning).
For example, Figure 16 F shows another exemplary side of the device of the mechanical impedance for measuring one or multiple teeth
View.In this example, orthodontic appliance (for example, rectifier 989) is fixed to tooth using multiple attachmentes 982.Rectifier
It including processor 991, radio communication circuit, and may include for detection sensor data to determine tooth and/or correction
Additional firmware, software and/or the firmware of the mechanical impedance of device.Attachment may include one or more sensors, including movement
(for example, accelerometer) and/or force snesor；These one or more sensors can directly (such as via electrical contact) with
Processor 991 on rectifier communicates.
In Figure 16 F, which can use as described above, and/or be determined for the input letter applied
Number frequency response.For example, any of these devices may include the actuating for applying vibration to tooth or power inputs
Device (for example, vibrating motor, minitype piston etc.).The power that actuator applies can be with the response that detects (for example, movement/acceleration
Degree evidence) it is measured together or is estimated and is used.Optionally, device be considered that the input of spontaneous power (for example,
Masticatory force), and them can be measured or estimated；As described above, using one or more force snesors.Force data and sound
Should move/acceleration information can be used for determining mechanical impedance.
Then obtained mechanical impedance data can be used for assessing the mobile health status of tooth.
Optionally or in combination, monitoring device described herein may include one or more gas flow sensings
Device is configured to detect whether wearing apparatus in mouth based on mouth interior air-flow.Match for example, gas flow sensor can be
It is set to the hot wire anemometer of the associated air-flow such as measurement and breathing, chewing, speech, snoring.The embodiments herein can be with root
The gas flow sensor based on microfluid is incorporated to according to needs.Optionally, gas flow sensor can also be used in measure air-flow with
Determine whether patient is undergoing sleep apnea event.For example, monitoring device can determine measurement flow pattern whether
Similar to the flow pattern occurred when patients experience sleep's apnea.For example, it is to sleep that this method, which can be used for utensil in mouth,
In the embodiment of dormancy apnea therapeutic appliance (for example, mandibular protraction equipment).It includes gas that Figure 17 A, which is shown according to the embodiment,
The monitoring device 1700 of body flow sensor 1702.Sensor 1702 is integrated into mouth in utensil 1704.In some embodiments
In, the sensing part (for example, conducting wire or conductor) of sensor 1702 extends from utensil 1704 (for example, lingual surface) to be exposed to
Mouth interior air-flow.The sensing data that sensor 1702 obtains can be by the other assemblies of monitoring device 1700 (for example, controller
1706) it is handled and is analyzed, to determine that utensil uses and/or whether patient is undergoing sleep apnea event.
Figure 17 B shows the monitoring device 1720 according to the embodiment including gas flow sensor 1722.In addition to sensing
Device 1722 extends through except the opposite side of utensil 1724, and equipment 1720 may be substantially similar to equipment 1700, so that sensing
Part is located at the near middle of mouth interior air-flow.This method can provide improved sensing accuracy.
Figure 17 C shows the monitoring device 1740 according to the embodiment including gas flow sensor 1742.In addition to sensing
Except device 1742 only extends from the side of utensil 1744, equipment 1740 may be substantially similar to equipment 1720.This method can
It can mitigate the discomfort of patient.
Optionally or in combination, monitoring device may include one or more motion sensors, this is one or more
Motion sensor is configured as detecting utensil use based on the movement of one or two in the jaw portion of patient.This motion-sensing
The example of device includes accelerometer, gyroscope, piezoelectric film vibrating sensor, gravity sensor and microwave emitter and receiver.
Motion sensor, which is desirably integrated into, to be worn in patient's upper jaw or epimandibular mouth in utensil, or can be distributed in and be worn on
It utensil on jaw and is worn on epimandibular utensil.In some embodiments, motion sensor is configurable to generate expression and suffers from
The data of the jaw portion Move Mode of person, and monitoring device processing and analysis motor pattern are (for example, use power spectrum and/or fortune
Dynamic credit analysis) determine whether mode indicates that utensil is being worn.Optionally, monitoring device can be distinguished living from different oral cavities
The dynamic associated jaw portion Move Mode such as (for example, chew, grind one's teeth in sleep, speech).
Figure 18 shows the monitoring device 1800 according to the embodiment using motion sensing.Equipment 1800 include one or
More motion sensors 1802, which, which is integrated into, is worn on patients jaw (on for example,
Jaw or lower jaw) on first in utensil 1804.In some embodiments, motion sensor 1802 includes one or more
Magnetometer detects the magnetic generated by being integrated into the magnet 1806 in second mouthful be worn in opposite jaw portion in utensil 1808
?.For example, equipment 1800 may include two multiaxis magnetometers, six axis for being used to obtain the relative movement of the upper jaw and lower jaw are surveyed
Amount.It in an alternative embodiment, is not that patients jaw can be measured with magnetometer 1802 relative to earth magnetic using magnet 1806
The angle of field, and angle-data can be used for determining whether utensil is worn.The exercise data generated by motion sensor 1802
It can be used for tracking jaw portion motor pattern, to determine whether utensil is currently being worn.It can also use other types of
Motion sensor 1802, such as accelerometer, gravity sensor, gyroscope or microwave emitter and receiver.
Optionally or in combination, monitoring device may include one or more temperature sensors, such as based on infrared spoke
Sensor, sensor based on conduction thermistor for penetrating detection temperature etc..Motion detector can be based on the temperature of measurement
No in body temperature (for example, oral temperature) come determine utensil use.Optionally, which can be related to the temperature that will be measured
The ambient temperature measurement obtained when not worn with utensil is compared.In some embodiments, temperature data is recorded
For original temperature value.It is alternatively possible to record temperature data, example with binary form (for example, temperature is whether in body temperature)
Such as to save memory space.
Optionally or in combination, monitoring device may include one or more strain gauges (for example, being based on resistance or being based on
MEMS's), at one or more positions in utensil in detection mouth stress and/or strain.Monitoring device can determine
Whether the stress and/or strain value of measurement are in the desired extent used for utensil.Monitoring device can store actual answer
Power and/or strain value, or only can have the binary data whether worn by storage indicator.
Optionally or in combination, monitoring device may include fluid (such as the saliva being configured to measure in ambient enviroment
Liquid) pH value one or more pH sensors.Monitoring device can the pH value based on such as measurement whether in human saliva
Expection pH within the scope of determine whether utensil is worn.
Optionally or in combination, monitoring device may include fluid (such as the saliva being configured as in measurement ambient enviroment
Liquid) conductivity one or more conductivity sensors.For example, monitoring device can the conductivity based on measurement whether
Determine whether utensil is worn in the desired extent of human saliva.In some embodiments, it can measure in a period of time
Interior conductivity.This method can be used for that monitoring device is prevented to be immersed in saliva to imitate fluid and be spoofed, because of human body
The conductivity of saliva can the physiological activity based on body change over time.
Optionally or in combination, monitoring device may include being configured as detection to contact with fluid in mouth (such as saliva)
One or more humidity sensors.For example, monitoring device can the humidity based on measurement whether oral cavity expection humidity model
It encloses and interior determines whether utensil is worn.
Monitoring device described herein can be used for substituting detection utensil using or with detecting utensil using in conjunction with measuring
The health and fitness information of patient.This monitoring device may include one or more biosensors, such as electrocardiography transducer, life
Object impedance transducer, photoplethysmographic sensor, electrodermal reaction sensor or combinations thereof.For example, photoplethysmo graph passes
Sensor can be used for measuring the blood volume variation of the mouth inner tissue (such as cheek or gum) of patient.It, can be with as another example
Carry out the electric conductivity of measuring mouth inner tissue using electrodermal reaction sensor, can be based on for example being discharged into outside organization from body of gland
Mineral on surface and change.In some embodiments, monitoring device described herein, which is configured as distinguishing, indicates that utensil makes
Sensing data and by it is other kinds of interacted with the patient of utensil (for example, utensil is held in patient's hand) generation biography
Sensor data.This differentiation can realize by training monitoring device, with distinguish data pattern that instruction utensil uses and by
The data pattern that other interactions generate, for example, based on the training dataset before actual patient monitors and/or during monitoring
The data of generation.Optionally or in combination, by its equipment other than monitoring device, such as by being obtained to by supervision equipment
The data obtained execute the ppu of post-processing, can also execute the differentiation.
Figure 19 shows according to the embodiment for monitoring the method 1900 of utensil in mouth used.This paper institute can be used
Any embodiment of the system and equipment stated executes method 1900.In some embodiments, using being operatively coupled to mouth
The processor of the monitoring device of interior utensil executes part or all in step.It optionally or in combination, can be by patient
The processor (for example, individually calculating equipment or system) of the equipment of oral external executes some or all of step.
In step 1910, from one or more sensor receiving sensor numbers for being operatively coupled to utensil in mouth
According to.One or more sensors may include any of sensor type described herein, including but not limited to: touch
Or touch sensor (such as condenser type, resistance-type), proximity sensor, audio sensor are (for example, MEMS (MEMS) wheat
Gram wind), color sensor (for example, RGB color sensor), electromagnetic sensor (for example, magnetic red sensor, magnetometer), light passes
Sensor, the force snesor resistance material of power (for example, depend on), pressure sensor, temperature sensor, motion sensor (for example,
Accelerometer, gyroscope), vibrating sensor, piezoelectric transducer, strain gauge, pH sensor, conductivity sensor, gas flow
Sensor, gas detection sensor, humidity or moisture sensor, biosensor are (for example, electrocardiography transducer, bio-impedance
Sensor, photoplethysmographic sensor, electrodermal reaction sensor) or combinations thereof.Sensor can be with utensil physics in mouth
Ground integrates (for example, couple, be embedded in, with its formation etc.), or can be positioned in oral cavity (for example, being attached to tooth), so as to
It is interacted with utensil in mouth.According to embodiment as described herein, sensing data can indicate whether utensil is currently being worn on
In the mouth of patient.
In step 1920, sensing data is handled to determine whether utensil is worn.For example, processing step may include
Determine sensing data whether with pattern match and/or fall into the range of the value worn of instruction utensil.Optionally or
In combination, processing step can include determining that whether sensing data is different from mode and/or is not worn positioned at instruction utensil
Value range except.Optionally, processing step may include by sensing data and the timestamp for indicating when acquisition data
It is associated, allow to determine temporal utensil use information.Processed sensing data may include that instruction utensil is worked as
The date-time that the duration and/or utensil that preceding utensil use information, the equipment whether worn uses are used.?
In some embodiments, step 1920 can optionally or additionally include processing sensing data to determine patient health information, such as
It is discussed in this article.
In step 1930, the sensing data generated in step 1910 and/or generated in step 1920 through locating
The sensing data of reason is optionally sent to remote equipment.Remote equipment can be mobile device (for example, smart phone), a
People's computer, laptop computer, tablet computer, wearable device, cloud computing server etc..It can according to need using wireless
Or wire communication method executes step 1930.Step 1930 can be performed automatically (for example, at predetermined intervals) or ring
Instruction that Ying Yucong remote equipment receives (for example, order that transmission sensing data and/or utensil use) executes.
Monitoring device described herein can be physically integrated into various ways in mouth in utensil.In some embodiments
In, during or after utensil manufacture, monitoring device is integrated into utensil.For example, monitoring is set after having manufactured utensil
It is standby that adhesive, fastener, blocking mechanism or combinations thereof can be used to be attached to utensil.Optionally, utensil could be formed with mutually
Feature or structure (for example, recess portion, recipient, guiding piece, hole etc.) are mended, reception is shaped as and accommodates monitoring device or its group
Part.
In some embodiments, monitoring device is coupled to device as prefabricated unit during or after utensil manufacturing process
Tool, such as by being inserted into and being sealed in the recipient in utensil, being attached to utensil (such as by blocking mechanism, adhesive, tight
Firmware).Optionally, monitoring device can utensil manufacture during or after on utensil assemble in situ.For example, by direct
Manufacture (for example, 3D printing) manufacture utensil embodiment in, can during manufacture or assembling utensil by manufacture
Afterwards, monitoring device can be printed simultaneously with utensil, is inserted into utensil.Optionally, some in monitoring device component can be with
It is prefabricated, and other assemblies can be assembled in situ.It should be appreciated that various manufacturing methods described herein can
To combine in various ways, to make the utensil with integrated monitoring device component.
Figure 20 A to Figure 20 D shows according to the embodiment for manufacturing the side of utensil in the mouth with integrated monitor equipment
Method.This method can be applied to any embodiment of monitoring device described herein and utensil, and can with it is described herein
Any of other manufacturing methods be applied in combination.In first step (Figure 20 A (top view) and Figure 20 B (side view)),
Prefabricated monitoring device 2000 is coupled to the positive model (positive model) 2002 of patient's denture.For example, monitoring device 2000
Adhesive and/or machanical fastener can be used to be attached.Optionally, monitoring device 2000 can be attached to model 2002 it
Before be hermetically sealed.In second step (Figure 20 C), (for example, thermoforming) is formed in monitoring device 2000 and model 2002
Material, so as to manufacturing appliance shell 2004.In third step (Figure 20 D), mold 2002 is removed, so that generating has embedded prison
The equipment shell 2004 of measurement equipment 2000.Optionally, 2006 (example of biocompatible adhesive can be used in monitoring device 2000
Such as, UV solidification glue), material layer or other sealing elements be packaged.
Figure 21 A to Figure 21 C shows according to the embodiment for manufacturing the side of utensil in the mouth with integrated monitor equipment
Method.This method can be applied to any embodiment of monitoring device described herein and utensil, and can with it is described herein
Any of other manufacturing methods be applied in combination.In first step (Figure 21 A), in the positive model 2102 of patient's denture
Form (for example, thermoforming) utensil 2100.In second step (Figure 21 B), such as use adhesive phase 2106 and/or fastener
Prefabricated monitoring device 2104 is attached to utensil 2100, and thermoplastic material 2108 is attached to the appearance of monitoring device 2104
Face.In third step (Figure 21 C), thermoplastic material 2108 is thermoformed to be formed monitoring device 2104 being encapsulated into utensil
Covering in 2100.Positive model 2102 can be for example removed before or after third step.
Optionally or in combination, this method may include being formed corresponding to the several of the monitoring device 2104 in positive model 2102
The positive geometry (for example, passing through 3D printing, CNC milling etc.) of what shape, so that utensil 2100, which is thermoformed, to be had for supervising
The recipient of measurement equipment 2104.Then monitoring device 2104 can be placed and is sealed in recipient.
Optionally or in combination, can by manufacture utensil (for example, by directly or indirectly manufacture), then for example using
Prefabricated monitoring device is attached to the utensil of manufacture by adhesive, fastener, locking mechanism etc., to make with integrated monitor equipment
Mouth in utensil.Optionally, monitoring device can be hermetically sealed (for example, passing through molding) before being attached to utensil.
Optionally or in combination, utensil can be by during or after forming utensil in the mouth with integrated monitor equipment
The flexibility of monitoring device and/or printing assembly are coupled on utensil to manufacture.Component can couple in various ways, such as hot
Molding, lamination, adhesive, coating etc..
Optionally or in combination, it can be used for the base portion of monitoring device by 3D printing, then will be used for monitoring device
Electronic building brick is built on base portion, to manufacture utensil in the mouth with integrated monitor equipment.In some embodiments, base portion by
Shape be meet wherein monitoring device by the tooth receiving cavity positioned and/or the geometry of target tooth.The 3D of monitoring device
Printing portion can be shaped as to be flushed with the surface of utensil, integrated in order to monitoring device and utensil.Optionally or combine
Ground, the surface that utensil can be etched by (for example, using masking process) then deposit to electrically conductive ink, Stretch material etc.
Utensil in the mouth with integrated monitor equipment is manufactured on etching part, with the electronic building brick for the monitoring device established on utensil
(for example, electric wire, connector, electrode etc.).
Figure 22 is the simplified block diagram that can be used for executing the data processing system 2200 of approach described herein and process.Number
It generally includes to be communicated at least via bus subsystem 2204 with one or more peripheral equipments according to processing system 2200
One processor 2202.These peripheral equipments generally include storage subsystem 2206 (memory sub-system 2208 and file storage
Subsystem 2214), one group of user interface input and output device 2218 and the interface to external network 2216.Interface signal
It is shown as to property " network interface " block 2216, and is coupled in other data processing systems via communications network interface 2224
Corresponding interface equipment.Data processing system 2200 may include for example one or more computers, such as personal computer,
Work station, mainframe, laptop computer etc..
User interface input equipment 2218 is not limited to any particular device, and usually may include such as keyboard, fixed point
Equipment (pointing device), mouse, scanner, interactive display, touch tablet, control stick etc..Similarly, various use
Family interface output device can use in the system of the disclosure, and may include such as printer, display (for example, view
Feel, be non-vision) it is one or more in systems/subsystems, controller, projection device, audio output etc..Storage subsystem
The substantially required programming of 2206 maintenances, including having the computer-readable medium and data knot of instruction (for example, operational order etc.)
Structure.The program module being discussed herein is generally stored inside in storage subsystem 2206.Storage subsystem 2206 generally includes memory
Subsystem 2208 and file storage subsystem 2214.Memory sub-system 2208 generally includes many memories (for example, RAM
2210, ROM 2212 etc.), including being deposited for storing fixed instruction, the computer-readable of instruction and data during program executes
Reservoir, basic input/output etc..File storage subsystem 2214 is provided for the lasting (non-easy of program and data files
The property lost) reservoir, and may include one or more removable or fixed drivers or medium, hard disk, floppy disk, CD-
ROM, DVD, CD-ROM drive etc..In storage system, driver etc. it is one or more can remotely located place, so via net
Server on network is coupled via internet/WWW.In this case, term " bus subsystem " is usually made
With to include any mechanism for making various assemblies and subsystem communicate with one another as expected, and may include that will be recognized
Know or be considered suitable for various suitable component/systems used herein.It will be recognized that the various assemblies of system can be but
Not necessarily in identical physical locations, but can be connected via various local area networks or wide area network media, Transmission system etc..
Scanner 2220 includes for obtaining the digital representation of patient teeth (for example, image, surface topology data
Deng) any device (for example, by the physical model of scanning tooth, such as casting (casts) 2221, by scanning from tooth
The impression of acquisition, or by directly scanning oral cavity), it can be obtained from patient or from treatment professional (such as orthodontist)
, and including digital representation is supplied to the device of data processing system 2200 for further processing.Scanner 2220 can
Other components to be located relative to system are distant far from and can be for example via network interface 2224 by picture number
According to and/or information be transmitted to data processing system 2200.Manufacture system 2222 is based on including receiving from data processing system 2200
The processing plan of data set information (data set information) manufacture utensil 2223.Manufacture machine 2222 can example
Such as remotely located place, and data set information is received from data processing system 2200 via network interface 2224.
Example
Any of the monitoring device described herein for being referred to alternatively as ECI and/or data logger can be wireless
Or pass through line connection (" wired connection ") or both.For example, when using the wire communication with monitoring device, it can be in device
Via one or more pins/contact attachment device on outer surface, is either wearing orthodontic appliance and/or be attached to correction
When utensil (such as rectifier), or after being taken out in utensil.It can be via the reader with one or more mechanical probes
Realize the data communication with monitoring device, the mechanical probes can serve as with electrode in monitoring device or in monitoring device/
Pad the electric contact of (pad).For example, probe can be located in shell or shell for holder, it then can be via indigo plant
Tooth is individually communicated with hand-hold electronic equipments (such as smart phone).Thus, for example, monitoring device can be via wired connection and shell
Body connection, then the shell can be by data (original or unmodified data or modification, analysis and/or formatting data)
It is sent to individual handheld device, such as smart phone.
Monitoring device may include one or more (for example, multiple) connection gaskets, and it is poly- can be encapsulated in selfreparing
It closes in object, opened when being inserted into probe and is retracted into original-shape after removing probe, to provide water-stop.It is optional
Ground or in addition, connection gasket can be exposed to except ECI, but when rectifier and/or ECI are in mouth or when with water/saliva contacts
It is grounded/disables.After reader probe is powered, ECI pad can switch to communication pattern.
Any of monitoring device described herein can be additionally configured to inactive configuration storage, wherein internal touching
Point some or all of it is disabled (for example, disabled by physics disconnection, gap, pin, barrier etc. battery and processor or its
Connection between his component), it can be manually or automatically removed (for example, connecting/reconnecting to power supply using preceding
Circuit), it is included in front of being removed in shell or packaging, before inserting the device into the mouth of subject, by monitoring device
Be connected to before dental instrument etc..For example, the apparatus may include via removing small pin to the mechanically activated of monitoring device.
In any of ECI device described herein, mechanical activation as described above/deactivation can be used and connect
It connects.Any one of these ECI (such as " data logger ") can be configured for wired (direct machine with reader
Tool/electrical) connection.ECI may include internal circuit (for example, any of ASIC and/or foregoing circuit, one or more
A sensor, memory etc.) and encapsulation or the battery that is at least partially enclosed in shell.Multiple data pads can reside in
The outside of the shell, so as to be electrically connected to internal circuit.It can be by protecting as described above, including the whole equipment padded
Property elastomer (for example, selfreparing elastomer) cover.The elastomer can be any suitable material, usually biocompatible
Electrically insulating material is selfreparing or self-sealing after penetrating.
Monitoring device (ECI) operation can be started by user, such as patient, dental technician etc., including use pin, bar
Deng mechanical activation.For example, user can remove activation bar before using ECI.When in situ, bar may will disconnect electricity
Connection between pond and circuit, it is ensured that the zero current of ECI circuit (for example, ASIC).When activating bar to be removed, battery can be with
It is connected to ECI ASIC, log-on data records series.During operation, as described above, the available raw sensory of ECI ASIC
Device data.For example, the device can be with 10 minutes interval acquiring original capacitances and temperature data, and each sample is stored in
In reservoir (for example, EEPPROM).Sampling interval can be counted as individual event, be converted into it is expected by intermediary interface equipment
Time interval display format.Therefore, described herein by eliminating the needs to real-time clock and related eeprom memory
Any of device can have size/area of coverage (footprint) of reduction.ECI may include by holding component
The shell (packaging) of the rigid material of internal circuit and battery portion composition, and can also include on shell and data pad
Elastomer coating.Even if when battery is completely depleted, such as if patient fails to deliver ECI in the service life of baby battery
Dental professional (for example, orthodontist) is returned to, data can also be fetched from the device.As optional modification, machinery is opened
The operation of motivation structure can be contrary to the above, so that ECI device is by insertion rather than removes activation bar, pin etc. to activate.
It, can be by including the spring contact stayed open by magnetic field rather than use activation bar/pin in other modifications
To provide similar Mechanical course or switch.In this example, device can be activated by removing it from the package；Work as packet
Permanent magnet (for example, being built in packaging/shell) in dress may make spring contact be kept away from circuit, by battery with
The rest part of circuit (for example, ASIC) disconnects, and the connection between battery and the rest part of circuit is disconnected, is also ensured that
The zero current of circuit.Removing device can permit spring contact closure from the package, data record sequence be activated, so that device
Available data (for example, with continuous 10 minutes interval acquiring capacitors and/or temperature data, and store data in storage
To be read from data pad later in device).
Although mechanical activation can be used under the background with the device for carrying out the data exposure pad of wired connection,
But it can be configured as mechanical activation including being configured as any one of those of radio operation device.
In addition, any of ECI device described herein can be configured as by user or dental professional insertion/
It is connected to orthodontic appliance (such as rectifier).For example, Figure 24 shows showing for the ECI device 2500 that rectifier 2502 can be inserted
Example.In this case, ECI device shown in is configured for wired connection (via pad 2507), however wireless ECI device can
To be similarly configured for being connected on rectifier 2502.Therefore, as described above, rectifier may include one or more guarantors
Feature (retaining features), including pin 2503 are held, as shown in figure 24.In some variations, the holding on rectifier
The mechanical connection between battery and circuit may be implemented in feature.In some variations, pin may be coupled to one on rectifier
Or more sensor.Pin can penetrate the molding material being likely to be present on any modification (including wireless and wireline connected device)
Material.
As set forth above, it is possible to which the intermediary interface equipment using such as shell or shell is examined from any of these devices
Rope data.When ECI device is configured for wired connection, intermediate equipment can be equipped with sharp probe, to be perforated through
Mold elastomer (over mold elastomer) is simultaneously in electrical contact with any data pad on PCB.Then, intermediate equipment
It can according to need retrieval, processing, calibration and encryption data, be then for example transmitted to the hand-held of such as smart phone via bluetooth
Equipment.Then patient and/or orthodontist, which can be used, can download to hold on smart phone or other mobile devices
Capable custom application software shows data on smart phone or other display mediums.
In any modification as described herein, identical pin can be used for connection and the electricity as the detection for salivary medium
Conductance sensing probe.
Although Figure 24 and Figure 25 show the connection gasket by crossing mold materials covering, connection can be exposed in some variations
Pad.For example, connection gasket can be exposed to except ECI, but in rectifier and ECI in the mouth of user or when with water/saliva contacts
It is grounded/disables.When reader probe is powered, ECI pad, which can switch to, can transmit the communication pattern of data in period.
Any of equipment described herein can also or be connected alternately through being wirelessly connected.Figure 25 is shown
One example of the ECI prototype constructed as described herein comprising one or more temperature and capacitance sensor.In the example
In, ECI 2603 is connected to rectifier (shell 2601).In Figure 25, prototype is relatively large；For example, by reducing processor, passing
The size of sensor and other internal components, actually may be much smaller.For example, prototype shown in Figure 25 may include
Texas Instruments FDC1004 capacitance-digital converter (area of coverage 10x8mm)；This area of coverage for example using
QFN rather than SOP encapsulation may greatly reduce size.Data logger may include on piece temperature sensing data logger
(for example, NFC type, such as THOR data logger).Exemplary prototype shown in Figure 25 can be connected wirelessly to centre
Equipment, and therefore can be the hand-hold electronic equipments of such as smart phone.
In either one or two of device as described herein, ECI may include capacitance type sensor, can be configured as even if
It can also accurately determine when device is present in tooth/multiple teeth when being immersed in water or imitating in the other materials of saliva
On, rather than except oral cavity.For example, prototype shown in such as Figure 25, which is used as concept, to be proved, to show that capacitance data can
With for determining when oral appliance is present in the mouth of user, rather than only it is submerged (or except oral cavity).In Figure 26
In, using every 5 minutes record capacitors (and temperature) of the equipment of Figure 25, continue 54 hours, while it is different to undergo equipment
Condition simultaneously observes capacitor.It (" is soaked as shown, the device can be distinguished to be worn (" touch " 2703) and be immersed in salt water
Not 2705 ").As described above, capacitance type sensor configuration can be configured as mutual capacitance measurement or self-capacitance measurement (is joined respectively
See such as Figure 27 A and Figure 27 B).Capacitance type sensor may be saturated, but use frequency range appropriate and/or ground connection ruler
Very little permissible capacitance detector circuit is distinguished due to the saturation degree of saturation degree and submergence in a fluid in mouth.
For example, Figure 28 and Figure 29 A-29C shows an example of ECI, being configured as differentiation can by wearing and script
Can provide be similar to when in fluid solution rather than the other conditions of the capacitance signal of capacitance signal that provide of while wearing.Scheming
In 28, ECI 2901 is shown as being worn on the tooth 2905 of subject, a part as rectifier 2903.Such case
Under rectifier be shown to have two sensing electrodes (A and B).First electrode (A) is configured as approaching when wear corrective device
Corona.Second (B) is configured as when being worn " remote " close to corona.Figure 29 A shows the ECI including A and B sensing electrode
Schematic diagram.Figure 29 B-29C shows how can use the capacitance signal from these sensing electrodes when equipment is real to distinguish
It is worn on border in mouth and when ECI outside mouth or is immersed in saliva shape environment.Logic for distinguishing these conditions is available
It can be measured by more accurate " wearing " or " not wearing " that ECI or the software/firmware/hardware by communicating with ECI export in determination
(for example, from the application software etc. run on smart phone).In Figure 29 B-29C, the signal from A contact sensor is shown
It is shown as and the signal alignment from B contact sensor.In this case, it is shown that three conditions and rough signal width
Degree.When ECI is outside mouth, the signal in A sensing electrode is low；Similarly, the signal in B sensing electrode is low.When equipment such as
When being worn shown in Figure 28, the signal in A sensing electrode is high (being greater than threshold quantity ACR), and the signal in B sensing electrode
Higher than signal when outside mouth, but it is lower than threshold value (BCR).However, when equipment is submerged in water, A sensing electrode and B sensing
Signal on electrode is all height, on ACR and BCR threshold value.Therefore, by the way that refusal is in A > ACR and B > BCR is as false positive
Reading when, the case where which can distinguish in mouth, mouth is outer and submergence.When A and B are below its threshold value, equipment outside mouth,
And when a-signal is higher than threshold value but B signal is lower than threshold value, which can be determined to be in in the registered permanent residence.
Figure 30 A- Figure 30 C shows another example of the method for distinguishing these conditions (in mouth, mouth is outer and submergence).
In this example, which can include a pair of of sensing electrode " A " 3001 and " B " 3003 again, however they are located at rectifier
On tooth either side on, and can be using the complex impedance measurement value Z between them.This " protection " electrode configuration can be with
False positive readings are distinguished using short detection pulse.The signal can be sensed with the degree of approach and is used in combination to increase the special of detection
Property.The placement of sensing electrode can be optimized to a possibility that minimizing false negative (for example, saliva is short-circuit).For example, electrode can
To be placed on the end of bow, as shown in Figure 30 C.In this configuration, when electrode is placed in water rather than against tooth
When, complex impedance Z can be 0.As shown in Figure 30 D-30E, when proximity sensor shows that actual capacitance is low, which exists
Outside mouthful；When proximity sensor show it is high or in contour capacitor, and when complex impedance measurement value is low, which may soak
Not in solution (for example, water), and therefore these measured values can be rejected as false positive.
When data (for example, data output) are wirelessly transmitted to the hand of such as smart phone by ECI device described herein
When holding equipment, the intermediate device of such as shell or tank (container) can keep only ECI module or device and/or its can
To keep utensil (such as rectifier) attached by ECI device and ECI device.Figure 31 A- Figure 31 D, which is shown, serves as intermediate equipment
Tank an example, receive near-field-communication signal from ECI module, and intelligent electricity sent for these signals by bluetooth
Words or other handheld devices.Since the size of ECI device is relatively small, it is accordingly used in any antenna module of wireless transmission signal
It also must very little；This may result in the problem of with smart phone or other device direct communications, because it is likely difficult to ECI
The antenna and smart phone of device or the antenna alignment of other hand-hold electronic equipments.In this case, such as Figure 31 A- Figure 31 D
Shown and description shell or support can be used for steadilying maintain utensil and ECI, and by any data of ECI record from
ECI is transferred to shell, is then communicated to the mobile device of such as smart phone, is transmitted to first using data as NFC from ECI
Then middle casing is transmitted to smart phone from middle casing as BLE.ECI can be maintained at by shell or other intermediate equipments
Predetermined position, including with one or more antenna alignments.Note that data can be between ECI, shell and mobile device to hold
Continuous mode is sequentially transmitted (for example, the delay between shell and mobile device is transmitted)；Delay transmission potentially contributes to
Determine when receiving device (for example, mobile device) is ready to receive data, and intermediate equipment may remain in data, directly
Indicate that its is ready to receiving device.In Figure 31 A, rectifier 3103 is assembled in shell 3101 so that ECI 3105 with
Reader antenna 3107 is aligned, for the reliable transmission via NFC.The intermediate equipment of such as shell can be passively (example
Such as, data are transmitted) or it can be active, such as modify, filter to data, annotating, analyzing, is average etc..
In general, near-field communication aerial (NFC antenna) can be all when ECI device is configured as wirelessly transmitting data
As the flat plane antenna of onboard antenna and/or it can be coil antenna.Figure 34 A and Figure 34 B show plane (onboard) antenna
Data are transmitted from the utensil comprising ECI data logger with the user of this antenna.In figure 34 a, onboard antenna is formed in base
On plate (for example, PCB substrate), and it is formed into a loop 3404 (or multiple circuits) and is connected to antenna circuit 3402.Onboard antenna produces
The field of the raw plane for extending substantially transversely to substrate.In Figure 34 B, rectifier 3407 can and adjacent antennas circuit 3404 attachment
ECI 3406 is aligned.In Figure 34 B, two individual NFC antennas are shown in the alternative view of ECI.On top, ECI days
Line is coil antenna 3411；Antenna in the ECI of lower part is onboard antenna 3413.
Figure 35 A shows the universal coil antenna (for example, being wrapped in the coil around ferrite bar) that can be used for NFC
Enlarged drawing；Figure 35 B shows the example using the ECI of coil antenna and reader.In Figure 35 B, ECI antenna 3505 and reading
Taking the coil antenna on device 3507 equally includes FERRITE CORE.Any of reader (centre including such as support
Equipment etc.) any antenna appropriate, including coil antenna and onboard antenna can be used.It, can be in device in Figure 34 B and Figure 35 B
Tool (being shown as rectifier) uses reader while being attached to ECI.
As described above, the NFC antenna in ECI device and the antenna and other hand-held electricity in phone (for example, smart phone)
Usually there is size difference between sub- equipment.Therefore, it such as may be present in the relatively large NFC loop antenna in smart phone
Energy transmission efficiency between much smaller ECI loop antenna (for example, usually only tooth is wide) may be very low, including by
It mismatches and causes less than 1% in antenna size.It therefore, may be beneficial, the energy coupler packet using energy coupler
A part as intermediate equipment (for example, booster etc.) is included, can be configured to shell, bracket, support or other devices.
Figure 36 A- Figure 36 C shows the passive NFC energy coupler 3603 that can be used.In Figure 36 A, circuit shows ECI
The use of NFC coupler 3603 between the NFC antenna 3601 of device and the antenna of smart phone 3605.It can be used any
The suitable a part of antenna as NFC coupler, including having the loop coil iron oxygen of air gap 3609 in FERRITE CORE
Body coupler 3607, as shown in figure 36b；ECI (or NFC antenna of ECI) can be placed in air gap.Figure 36 C shows use
The total system of NFC coupler couples prediction.
Figure 37 A and Figure 37 B show the use that may be used as NFC to the NFC coupler prototype of intermediate equipment.Such as Figure 37 A
Shown in, ECI device (being shown schematically as with coil antenna) 3701 is located in the range of NFC antenna 3703, shows at this
The coil antenna (for example, 6mm loop antenna) with air gap Yu ferrite coil is shown in example.Then NFC coupler is used
The second antenna 3705 retransmit the signal that receives from NFC antenna, be placed on the second larger day to be sent to by NFC
Phone 3707 in the range of line 3711.As described in will be in Figure 39, first antenna can with ECI antenna match, and
And second antenna can be with the antenna match in phone.In addition, NFC coupler device can provide telephone antenna and second day
Line 3711 and the alignment between ECI antenna and first antenna, and phone and/or ECI can be firmly held in this
Position.Prototype shown in Figure 37 B further includes indicating that adjunct circuit (for example, amplifier, filter etc.) 3413 can be used
In modifying before the data-signal received from ECI is passed to phone to it.In general, can be held at this stage
Any signal processing of row or signal can be only passed.In one example, 3dB attenuator is located at 3703 He of first antenna
Between second antenna 3711.
Figure 38 is shown and the prototype of the similar NFC coupler schematically shown in Figure 37 A and Figure 37 B.In Figure 38,
Rectifier with ECI is placed on NFC coupler, so that ECI antenna is aligned (in Figure 38 with the NFC antenna of NFC coupler
It is invisible).The phone for receiving the signal transmitted on NFC coupler is located at the telephone antenna overlying regions of NFC coupler.Figure 39
Show the schematic circuit diagram of the device of Figure 38.In this illustration, a pair of of current divider (C1, C2) and a series of capacitors (C3,
C4 the inductive impedance of two NFC coupler coils) is converted into the resistive impedance at circuit center, is eliminated in system significantly
Impedance mismatching loss.
It is transmitted except data except through intermediate equipment (such as shell or other relays) from ECI, in some modifications
In, ECI can be configured to be used for (in some variations, in conjunction with other systems component, including hardware, software and/or firmware)
Data are transmitted directly to the mobile hand-held device of such as smart phone (for example, NFC is to NFC communication, or optionally from ECI
NFC is to bluetooth or other wireless protocols).For example, Figure 32 is shown for directly sending mobile hand-held device from ECI for data
System the first example.In Figure 32, label or guiding piece (for example, paster, applique, phone cover/shell, sleeve etc.) can
With instruction for placed on phone 3203 ECI or rectifier/utensil position 3201 or place with reliably (for example, via
NFC) smart phone is transferred data to from ECI device.In Figure 32, leader label is a part of applique 3205.
In some variations, the application software in mobile device (for example, phone) can also provide the alignment for ECI
Guidance is included therein on the screen for placing ECI device and/or utensil and ECI and indicates.It, should when ECI is in good alignment
Software can also be indicated by vision, audio or both, and user's correction/adjustment is allowed to be aligned.For example, Figure 33 A is shown
Another example of direct communication between ECI and smart phone.In this example, the data for from ECI to phone 3301 pass
The application software sent indicates where positions ECI by showing alignment area 3303 on the screen of phone.In Figure 33 B- Figure 33 C
In, show the additional support or interface 3305 ECI being firmly held on phone, Figure 33 C shows support 3305
Use ECI being maintained in the optimum target of data transmission.In this example, data sink is can to help to be directed at ECI
To transmit the mobile/handheld equipment (for example, smart phone) of data, such as Figure 33 B and Figure 33 C.In these diagrams, mobile device
Screen show the target that can indicate the position of placement of the ECI relative to mobile device, in smart phone
Optimal communication between antenna (for example, such as NFC antenna) and ECI.In this example, (it is plotted as target eye to target, but can
To be any label or indicator 3303) it is shown on the screen, and user can be with the target of manual alignment " clip " 3305
Compatible portion, for positioning the opposite of target 3303.This allows to be attached to or the ECI on clip (see the top of Figure 33 C) is protected
It holds optimally aligned.Mobile device can based on one or more standards (including hardware (for example, mobile device) configuration, model
Deng) determining the position of target 3303, known location of such as antenna in the equipment of particular brand and model can be by grasping
Application method (for example, software) determination for making mobile device (is shown as " searching my antenna " application side in Figure 33 B and 33C
Method).In some variations, application method can be by the feedback between receiver (mobile device) antenna and ECI equipment come based on
Calculate 3303 position of target.
Can also be directed at and/or keep ECI device and telephone communication using other registration mechanisms and technology be used for by
Data are wirelessly transmitted to smart phone from ECI.For example, in some variations, magnetic force can be used by ECI and be attracted to target position
It sets.Other machinery aligning guide can be used to be fixed as being aligned with the antenna area of phone by ECI device.For example, can make
With including for by the phone case of low-lying/holding area of the antenna alignment of ECI and phone or lid (for example, sleeve).?
In some modifications, installation part/lid/sleeve may include one or more pins so that ECI equipment to be held in place.
As described above, any of apparatus described herein (including system) can via smart phone (or its
His hand-hold electronic equipments) on the control software that runs communicated with the hand-hold electronic equipments of such smart phone.The application software
It can be connect with electronics compliance indicator interface, and the electronics compliance indicator using NFC and BLE agreement can be enhanced
(ECI) wireless communication between.The application can be by being incorporated to the mechanism (such as stimulation, game etc.) for encouraging compliance
ECI is supplemented or augmented, and data processing, visualization and/or data sharing from ECI can also be provided.ECI device is logical
It often can recorde the sensing data from the patient for wearing orthodontic appliance (such as rectifier).Data can store on ECI
Physical storage in, and retrieved by another equipment, such as using NFC and BLE technology as described above (or NFC and NFC),
Smart phone is allowed to retrieve data.Smart phone application (app) can be made of several components, and some of components are being schemed
41, it is described in Figure 42 and Figure 43.For example, schematically showing NFC/BLE communication control in Figure 41.In addition, Figure 44, figure
45A-45B and Figure 46 schematically shows the mode of operation of ECI equipment, and in equipment and teleprocessing unit (for example, intelligence
Phone) between communication control.
Handling can be coordinated with the wireless communication and data transmission of ECI by application software.Using event being issued
To the other elements that may include application, such as: main screen or user interface (UI) manager, it can be in response to event (example
Such as, " activation card " event, as shown in Figure 41-Figure 42, when ECI is initially opened and receives confirmation return) to provide a user
Notice or starting are welcome or instruction screen；And/or it is able to respond in data transmission (for example, " uploading successfully " in Figure 43) event
Data analysis management device.Application software can be generated the display including figure, and can in data searching modes with
Improve accuracy/specificity/sensitivity of compliance data.It can issue " low compliance ", " high compliance " etc.
Event.See, for example, Figure 40 (centre), it is shown that for including user circle for the exemplary application software that intelligent compliance monitors
Face.
Certain components of application software can not exist or run (on smart phone) local, and can be in remote service
It is run on device.For example, data history and data analysis can be with trustships on the remote server.In this case, application program
It is also possible to have and uploads data to the server and the component from the server downloading data.
Application software can help the operation of the ECI on user management utensil and/or utensil, including beginning/stopping is fixed
When/sensing/record, and/or data, activation/deactivation ECI etc. are transmitted to ECI/ from ECI.The event issued according to normal use
Can be used for that ECI system is supplemented or augmented from application software.For example, application software can manage lead to relevant to utensil and/or ECI
Know or remind and/or can be by starting timer come response events (for example, " activation block " event), which can be at it
Another event is issued when expired.One possible response of the event can be to user's sending out notice to remind user will
ECI equipment is connected to phone.The notice can be alarm, Email, short message etc..The service can also be by notifying other companies
The user (for example, parent or doctor) that connects responds " low compliance ".
Application software can be with coordinate responses in particular event relevant to wearing/use orthodontic appliance as described herein
Stimulating system.For example, application software may include or operate with virtual reward (for example, coin, trophy, RPG element " rise
Grade "/promote your smile, integral etc.), the game of monetary incentive (for example, discount, discount coupon, Gift Card etc.), and/or motivate
Information.For example, when " activation card " event occurs, output -> " you have activated your first rectifier！You are with your side
The smile of the happy health of formula ".After download event, particular message may be shown or transmitted to user according to data, for example,
" rectifier that this week wears you is done a good job " " only needs again more 2 rectifiers！" etc..
Figure 42 is shown as described herein for controlling the potential flow chart of the application software of NFC, including detection ECI.
Figure 43 shows the potential control figure of the application software for controlling data processing.
The example of the mode of operation for ECI equipment is shown in Figure 44, shows equipment (for example, having monitoring sensing
The utensil of device, as shown in ECI) and the teleprocessing unit of such as smart phone between communication interaction.In Figure 44, equipment exists
Various power down and wherein NFC are between the recording status of activity or removal and convert.Other possible states may include wherein remembering
Record the activity pattern being completed, and the activity pattern with real-time measurement.
Figure 45 A-45B shows reception processor (such as intelligence electricity operated on it by control logic (for example, software)
Words) management that is communicated；Figure 45 A-45B shows one that how phone/receiver application program can show and interact and shows
Example.For example, smart phone can be according to smart phone and with the orthodontic appliance of sensor (for example, ECI) in Figure 45 A-45B
Between communications status, wait BLE pairing, wait NFC and attempt downloading, or wait NFC and attempt downloading between switch.It is logical
Letter manager (for example, software/firmware on smart phone) can be responsible for managing BLE or only NFC communication.It can issue thing
Part, so that external module or administrator can operate on it (for example, data management system can be to " data downloading " event
Operation is executed, and another component (being not shown herein) can operate " data upload " event).Similarly, Figure 46 shows
The example for data handling component/manager procedure chart is gone out.
Present disclose provides improved system, method and the dresses of the physiological characteristic in oral cavity and respiratory tract for monitoring patient
It sets.Utensil is equipped with the sensor for being configured as sending and receiving signal, and the place these signals being recorded in memory
Manage device.Signal be can analyze to determine the physiological characteristic of patient.Utensil is also possible to therapeutic appliance in mouthful, treats potential disease
And physiological characteristic is monitored to track the effect of the treatment.
As it is used herein, term "and/or" is used as functional word to indicate that two words or expression will be by together
Using or be used alone.For example, A and/or B include individual A, individual B and A and B together.
Present disclose provides the physiological characteristic for monitoring patient and the treatment parameters for assessing such as utensil effect
Abnormal correction system, device and correlation technique.
In an aspect, a kind of method for monitoring the physiological characteristic of patient is provided.This method includes will be in mouth
Utensil is located in the oral cavity of patient.Utensil is shaped as the tooth for receiving patient in mouthful, and including multiple electrodes, Mei Ge electricity
Pole is positioned to be in electrical contact with the different piece in the oral cavity of patient.This method further includes measuring electrical impedance simultaneously using multiple electrodes
And physiological characteristic is determined based on electrical impedance.In some embodiments, measure and determine step by be arranged in mouth on utensil or its
Interior one or more processors execute.
In some cases, physiological characteristic includes one of the following or more: respiratory tract diameter, respiratory tract volume,
Resistance of respiratory tract, lung liquid level, soft tissue be crowded, respiratory rate, muscle activity, the ion composition of saliva or the ion of oral mucosa
Composition.Physiological characteristic may be related with the sleep disturbance of patient, and sleep disturbance may include sleep apnea, snoring or
One of bruxism or more.In some embodiments, sleep disturbance includes sleep apnea, and utensil quilt in mouth
It is configured to treatment sleep apnea.
In some cases, in mouth effect of the utensil when treating sleep apnea be based on determining physiological characteristic come
It determines.One or more processors, which can be configured as, makes the determination.
In some cases, electrical impedance includes near field impedance, and physiological characteristic includes that soft tissue is crowded, ion of saliva
One of the ion of composition or oral mucosa composition or more.In some cases, electrical impedance includes far field impedance, and
Physiological characteristic includes one or more in lung liquid level or respiratory tract length.
In another aspect, a kind of method for monitoring the feature in patient oral cavity or respiratory tract is provided.This method packet
It includes and utensil in mouth is located in the oral cavity of patient.Utensil is shaped as the tooth for receiving patient in mouthful, and including transmitter
And receiver.This method further includes that transmitter is made to emit signal in the oral cavity of patient, is connect in response to the signal use emitted
The signal that device measurement is returned from the oral cavity of patient or respiratory tract is received, and the oral cavity of patient is determined based on measured signal or is exhaled
Inhale the feature in road.In some embodiments, measure and determine that step is one or more on utensil or in it by being arranged in mouth
A processor executes.
It while reference has been made to include the utensil of polymer shell-type utensil, but embodiment disclosed herein is highly suitable for receiving
Many utensils of tooth use, such as one or more of utensils without polymer or shell.For example, the utensil can be used
Such as many of metal, glass, reinforcing fiber, carbon fiber, composite material, enhancing composite material, aluminium, biomaterial and combinations thereof
One of material or more is made.For example, the utensil can shape in many ways, such as made using thermoforming or directly
Make (for example, 3D printing, addition manufacture).Optionally or in combination, it can use machining manufacture utensil, such as utilize meter
The utensil that the digital control mechanical processing of calculation machine is manufactured by material block.
Figure 47 shows the impedance model of patients with respiratory tract 4700.Respiratory tract 4700 include oral cavity, on upper jaw side by
Hard palate 4701 and soft palate 4702 define, are defined on lower jaw side by tongue 4703 and maxilla and defined in side by cheek.
When a patient is breathing, air-flow 4704 passes through mouth and nasal sinus and travels downwardly along the upper respiratory tract 4705 towards lung.These channels
Obstruction can cause sleep apnea, and for instance it can be possible that due to such as soft tissue squeezes or upper respiratory tract part narrows feelings
Condition.The respiratory tract of patient can be modeled as the substantially cylindrical channel between oral cavity and lung.In some embodiments, suffer from
The tracheae of person be approximately external shell 4712 with soft tissue and filled in air hollow 4714 length be L cylindrical body
4710.The conductivity of soft tissue is much higher than the conductivity of air；Therefore, the impedance of respiratory tract can be approximately with outer radius
In R (radius of the tissue of the respiratory tract in neck), inside radius r (respiratory tract radius) and length L (respiratory tract length)
The resistance of hollow cylinder.Electricalresistivityρ can be approximated to be the resistivity of respiratory tissues, and impedance 4720 can pass through equation
Z=ρ L/A estimates that wherein A is total conductive area --- it is internal (substantially non-to be in this case that exterior circular column area subtracts
It is conductive) cylindrical body area.These give the total impedances 4720 of about Z=ρ L/ π (R^2-r^2).More generally, in some embodiments
In, impedance will be directly proportional to the length of the resistivity of soft tissue and respiratory tract, and the cross-sectional area with the conductive tissue of respiratory tract
It is inversely proportional.For the electric signal advanced between oral cavity and lower respiratory tract, the upper respiratory tract can be accordingly regarded as circuit element, special
Sign is the impedance Z similar with party's formula.Impedance Z depends on inside radius r, increases Z in particular with r and increases, and as r subtracts
Small Z reduces.Therefore, it is changed with time by measuring impedance, respiratory tract width can be determined according to corresponding impedance variations
Variation.
The variation of respiratory tract width is particularly important for the patient with sleep apnea and related disease, because of sleep
It is not wide enough that obstacle and snoring may originate from respiratory tract.Figure 48 A shows the patient respiratory road width for different Mallampati scores
The variation of degree.The patient that Mallampati is scored at I has big without hindrance respiratory tract, wherein hard palate 201, soft palate 202, small
Tongue 203 and pillar 204 are visible；The patient that Mallampati is scored at II has lesser respiratory tract, and wherein pillar no longer may be used
See；The patient that Mallampati is scored at III only has hard palate and soft palate and uvula root visible；And Mallampati is obtained
The patient for being divided into IV only has hard palate visible.Higher Mallampati score may be with the sleep apnea phase of bigger possibility
Association, wherein Grade III and Grade IV are especially it is possible that sleep apnea.
As can be seen that in some embodiments from Figure 48 A, the without hindrance cross-sectional area of the respiratory tract of patient with
The increase of Mallampati score and reduce so that higher Mallampati score is associated with lesser respiratory tract area.
As discussed with respect to FIG. 1, lesser respiratory tract cross section likely corresponds to lower electrical impedance.Figure 48 B is shown
Correlation between Mallampati score and respiratory tract impedance draws Mallampati score relative to inverse impedance 1/Z.Because
Increase 1/Z and correspond to increase Mallampati score, it is possible to be determined using the measurement of the electrical impedance along respiratory tract
Mallampati score.The utensil permission that impedance can continuously or be constantly measured when being worn by patient is for example slept in patient
Respiratory tract width is continuously monitored when feel.It can be used for diagnosing and treating sleep apnea by the data that this measurement generates.
In some embodiments, present disclose provides for measuring patient based on electrical impedance oral cavity and/or respiratory tract
The system of feature, method and apparatus.The example for the feature that can be measured includes respiratory tract diameter, respiratory tract volume, breathing
Road resistance, lung liquid level, soft tissue be crowded, respiratory rate, muscle activity, the ion composition of saliva or the ion group of oral mucosa
At.It can be measured based near field impedance, far field impedance or combinations thereof.As it is used herein, near field can refer to along or
The measurement of the impedance of shortest path between two electrodes.For the electrode in mouth, for example, near field impedance can be impedance
Depending on the resistivity of oral tissue and the part of shape or part of it.Near field can be used for measuring such as muscle activity, saliva
The ion of liquid form or oral mucosa from molecular feature.It depends on as it is used herein, far field can refer to far from two
The impedance measurement of the feature of shortest path between a electrode.For the electrode in mouth, for example, far field impedance measurement can measure
Due to the shape or resistivity of the tissue in the upper respiratory tract or lower respiratory tract or in lung variation and to the influence of impedance.For example,
Far field can be used for measuring that such as respiratory tract diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level, soft tissue be crowded, respiratory rate
Etc. features.Impedance can be measured between the two o'clock or more in patient oral cavity is put.It the position of measurement point in oral cavity can root
Change according to needs.For example, electrode can be placed on the opposite side of oral area, at the upper jaw and epimandibular point, same jaw portion (on
Under or) on point at, or contact tissue, such as cheek, palatine, gum, tooth.Electrode can be configured as example with 1mm,
Point in the separation contact mouth of 2mm, 4mm, 10mm, 20mm, 40mm, 100mm or 200mm.For example, shorter separation may be to close
Field measurement is more sensitive, and longer separation may be more sensitive to far-field measurement.
Figure 49 A shows the oral cavity 4900 of patient, in conjunction with the sensor that can place such as electrode with measure oral cavity and
The point of the feature of respiratory tract.One butt contact 4910 and 4920 is located in oral cavity 4900.One contact point is along arcus dentalis superior 4912
Gum positioned in tongue side.Although being shown in close to the subsequent right tongue side of oral area, as shown in Figure 49 A, contact point 4910
Position can change；For example, in some embodiments, contact point 4910 is located at the cheek side of arcus dentalis superior or the left side in oral area,
Or at any point along arcus dentalis superior or inferior dental arch, including optionally on dental arch identical with contact point 4920.Contact point
4910 can also be at the certain point along the cheek of patient.Similarly, although contact point 4920 be shown as with tongue 4924
Along the gum of inferior dental arch 4922 on opposite cheek side, but contact point 4920 can also be in a manner of identical with contact point 4910
Variation so that effective contact point any for one can be the contact point for another, including but not limited to along hard palate,
On the tongue of one or more dental arch at any other point along the cheek of patient, or in oral area and/or cheek side
Contact point.The position of each contact point pair influences the sensitivity of the measurement executed with a pair of point.
For example, the specific choice of the contact point with reference to shown in Figure 49 A, since the respiratory tract of patient is stretched out from oral cavity, so
It respiratory tract channel may be relative to electrical impedance substantially in far field.Therefore, in some embodiments, it is preferred that by near-field signals
Remain it is as reasonably small as possible, to maximize the relative size of far-field signal.Therefore, in some embodiments, 4910 are put
With 4920 be preferably positioned in the oral cavity and oral area it is subsequent near remotely；In Figure 49 A, shown with positioned at mouth
The point 4910 near upper molar on the side in portion, and put near the lower molar on the other side that 4920 are located at oral area.
It can be by applying voltage appropriate come induced current to flow between contact point (such as putting 4910 and 4920)
It is dynamic, and these electric currents can be measured to determine electrical impedance.For example, voltage can be alternating voltage with induced AC current.It can
With incude include many frequencies current impulse, with allow each of multiple and different frequencies place simultaneously and/or sequentially
Measure impedance.In some embodiments, although such as point 4910 and 4920 contact point between electrical impedance a part be by
Caused by near field impedance, but a part be also likely to be due to far field impedance (including respiratory tract impedance) caused by.Farther place
Contact point may be intended to more sensitive to far field relative near field, and the point being close together may be relative to far field to close
Field is more sensitive.The principle also can be applied to using sensor rather than the measurement that carries out of electrode, all hairs as disclosed herein
Emitter-receiver pair: close transmitter-receiver is to can be more sensitive near field, and isolated transmitter-receiver is to can be right
Far field is more sensitive.
The measurement result of such as impedance measurements can be filtered, to separate due to variable to be measured and its change
The part of measurement amount and its variation caused by change.For example, by applying voltage pulse between point 4910 and 4920, electricity
Stream pulse can be incuded, and be then received, then measured return signal again.Signal can be used as the function of time to track.
Time needed for pulse advances to lung and back can correspond to round-trip distance divided by rate of current, and rate of current can be light
A big chunk of speed.Using time enough resolution ratio, such as nano seconds resolution, pulse can be determined based on its two-way time
Travel how far；By the way that respiratory tract can be obtained in the round-trip delay time measurement signal strength for corresponding to the pass respiratory tract
Far field impedance direct measurement.In some cases, the relative phase of current impulse can be measured to determine far field impedance, because
It may be influenced by time delay for phase.
A part of near field impedance will also depend on respiratory tract width because point 4910 and 4920 between along oral cavity table
The available path in face includes the path advanced near respiratory tract opening.If respiratory tract opening is smaller, shorter path can
With it reduce the impedances near field.Impedance can also duplicate measurements over a longer period of time, to allow preferably filter noise
Simultaneously influence of the respiratory tract change width to impedance is isolated in source.For example, respiratory tract changes shape when a patient is breathing, therefore can make
The impedance variations as caused by respiratory tract change width are isolated with the variation of respiratory tract impedance relevant to patient respiratory.It is similar
Ground, for other measurements, impedance or the variation of other measurement characteristics can be related to the particular measurement；For example, can be according to close
Field impedance change determine ion saliva contents variation, and can according to response in the measurement of the power applied by actuator plus
Speed determines the physical characteristic of tooth or tooth PDL system.It should be appreciated that point 4910 and 4920 can be in whole oral cavity
Interior variation is to change measurement sensitivity and specificity；For example, in order to determine the appropriate location for measurement sensor position, it can be with
Multiple points pair are tested in patient's oral area, and can choose the point with highest signal to noise ratio for the measurement to for being somebody's turn to do
Patient or other patients.Other measurements (such as transmitter-receiver measurement) can permit for their own measurand
Identical mode is followed, and can be equally placed at the variable position in whole oral cavity, it is corresponding for its to change them
The sensitivity and specificity of measurement.
Figure 49 B shows the optional position of the characteristic in the sensor measurement oral cavity and respiratory tract that can place such as electrode.
In sensor configuration 350, first sensor 360 is positioned along the upper jaw jaw near soft tissue 362 and uvula 364.Second passes
Sensor is positioned along the lower jaw jaw between tongue 374 and mandibular teeth (not shown).In this embodiment, sensor is located at respiratory tract
Opposite side so that respiratory tract is located on the shortest path between two sensors.In the feelings that sensor 360 and 370 is electrode
Under condition, for example, the impedance between two sensors will partly depend on the width of respiratory tract, wherein lower impedance correspond to compared with
The respiratory tract of narrow (and therefore more blocking).
In some embodiments, impedance measurement as described herein is executed using the electric transducer for being coupled to oral appliance.
The example of this oral appliance includes tooth retainer, rectifier and mouthguards.In some embodiments, oral appliance is for controlling
Treat sleep apnea, such as mandibular protraction equipment.In some embodiments, patient wears mandibular protraction equipment, so as to opposite
Lower jaw is shifted forward in the upper jaw to treat sleep apnea.Mandibular protraction equipment can be utensil that patient can be removed (for example,
Patient can place and remove utensil with the help of not obtaining doctor), it is inserted into before sleep in the oral area of patient, with
Just lower jaw is maintained to remove in front extended position and while patient awoke from patient's oral area to allow just during sleep
Often activity.In an alternative embodiment, in mouth utensil may include be not patient can be removed one or more components (for example,
Attachment or bracket fixed to one or more teeth, the anchoring device being located in the oral cavity tissue of such as bone).One
In a little embodiments, utensil includes at least one utensil shell in mouth, with multiple single jaw portions for being shaped as reception patient
The chamber of tooth.
Any amount of sensor, such as electrode, acoustic transducer and accelerometer can be used.Sensor can be located at
At any part of utensil, the tongue side of such as adjacent gum or cheek side, the dental surface of abutment teeth, adjacent cheek or along mouth
The top or bottom in portion.Sensor can be coupled to utensil in various ways, such as by adhesive, fastener, be embedded in device
Have in material, or is inserted into the chamber formed within the appliance.Measurement described herein, which can be used to be coupled to, is worn on patient's
The sensor of the upper jaw or epimandibular single utensil obtains.Optionally, sensor can be respectively distributed to be worn on the upper jaw under
Between a pair of of utensil on jaw.In some embodiments, when being worn, oral appliance and sensor are completely contained in patient's
In oral cavity.For example, in some embodiments, external power supply, control electronic device or external sensor point can be not connected to
In the case where operation utensil.Engine electronic equipment may include the power supply of such as battery to store the energy for continuous operation.
For example, battery can be it is chargeable, for example, utensil is inserted into charger or by using wireless power transmission when not in use
It charges, in the latter case, utensil may include the appropriate antenna for receiving the electric power of transmission from base station.Oral cavity device
Tool and sensor can be what patient can be removed, allow to execute measurement, without sensor device to be implanted into patient tissue
Or oral area or tooth fixed to patient.
Figure 50 A- Figure 50 G shows various oral appliances comprising electric transducer is (such as with the various electricity with placement location
Pole), to allow to measure other physiological characteristics of the impedance due to caused by respiratory tract change width and patient, including patient mouthful
The feature of chamber or respiratory tract.Electrode can be used for monitoring intraoral resistance variation, such as in the patient for having abnormal soft tissue crowded
In, the conductive path between electrode may be shorter.Because the stretching of soft tissue can change during the variation in mandibular location
Intraoral conductive path, it is possible to detect whether patient has the oral area for opening or closing using impedance measurement, such as
Or whether lower jaw moves back or stretches out.Although in some embodiments, the electrode of good separation may be that expectation increases to far field
The sensitivity of impedance variations, but the electrode closely positioned can be used for the physiological characteristic of monitoring patient.For example, thin by muscle
The current potential that born of the same parents generate during activation can be monitored by the electrode suitably positioned.Can be by monitoring flesh in this way
Meat move and in the physiological activity that detects be remporomandibular joint occlusion, in dysfunction activity (such as grind one's teeth in sleep or tightly grit one's teeth)
Period increased masseter activity, and, for example, since the upper respiratory tract caused by the upper respiratory tract collapsing or decline aprowl is loose
It relaxes, it is associated with hypopnea or apnea.
Although using electrode as the illustrative sensors in the orthodontic appliance shown herein, other than electrode
Sensor can also be used for sensing for example, by measuring the characteristic (such as piezoelectric pulses, sound wave and acceleration) other than impedance
The oral cavity of patient and/or the physiological property of respiratory tract.It in some embodiments, can be by transferring signals to the mouth of patient
In chamber and/or respiratory tract and measurement measures physiological property from the response signal of oral cavity and/or respiratory tract return.Response signal
Feature (for example, amplitude, frequency etc.) can oral cavity and/or respiratory tract based on patient characteristic and change.
In such embodiments, the electrode marked in Figure 50 A- Figure 50 G can be with sensor appropriate to replacement, respectively
As transmitter and receiver.For example, energy converter can be used for generating and receive sound wave (for example, ultrasonic wave), and can make
Oral cavity or the upper respiratory tract are imaged with the phase and amplitude information of response signal.Actuator (such as piston, vibrating motor
Or piezo-electric crystal) and accelerometer can substitute corresponding electrode.Tooth can be sent by pulse signal via actuator, and
And the accelerometer recording responses signal with teeth contact can be used.This response can be with the different phase phase of teeth training
It closes, such as the movement caused by the orthodontic force that is applied by utensil shell, because the rigidity of tooth-PDL structure will be with tooth
Mobile different phase and change.Even if not causing tooth mobile by utensil shell, the response may also with tooth, root of the tooth and/
Or PDL health is related.Actuator can also be placed with generation and can generate electric current in oral structure (such as imitates via piezoelectricity
Answer) power.For example, the compression of bone and collagen leads to movement of the electronics in lattice, and applied force can lead on tooth
To the short piezoelectric effect of alveolar bone, this can be detected by receiving sensor appropriate (such as electrode).By alveolus and tooth
The electric signal that all ligaments (PDL) generate under a load can stimulate the variation of bone metabolism, and the electric transducer of such as electrode also can be used
In for example detecting these electric signals by the variation of monitoring voltage.Measurement these examples can be combined with execute simultaneously or
Staggered measurement, including the combination with impedance and the electrode measurement of other electrical characteristics.In some embodiments, multiple surveys are executed
It measures and its result is compared or is combined using sensor fusion techniques, to improve the resolution ratio of the amount of each measurement.
Figure 50 A shows the wearable utensil 5000 on patient teeth comprising the diameter in patient oral cavity 5002
Sensor at opposite point.Utensil 5000 includes shell 5004, and Tooth receiving cavity, which is configured to work as, is worn on patient mouthful
The tooth of patient is received when in portion 5002.Utensil shell includes protrusion 5005, be configured to when utensil is worn along
The cheek of patient extends.For example, protrusion may be configured to the protrusion for the utensil that engagement is worn in opposite jaw portion,
To provide the power for being used for mandibular protraction.The utensil further includes multiple sensors, such as electrode, and wherein first electrode 5006 is arranged
Over the projections, and the right cheek contacts with patient when worn are oriented.Second electrode 5008 is arranged on shell and determines
Position at when worn with the left cheek contacts of patient.The diagram in patient oral cavity 5002 is shown when utensil is worn by every
The point of a electrode contact.Electrode be positioned to contact patient oral cavity rear portion near substantially opposite point, with shown in Figure 49 A
Electrical pickoff is provided in similar region.As a result, for example, electrode position is very suitable for measuring far field impedance.In optional implementation
In example, as discussed herein, utensil 5000 can also be used to execute other kinds of measurement.
Utensil 5000 further includes the wiring appropriate being arranged in shell 5004, provides sensor and (is shown as electrode 5006
And 5008) and the electrical pickoff that is arranged between the processor in shell.Processor is also connected to the battery for such as providing electric power
Power supply.Processor is configured as controlling the voltage value at each electrode, with allow generate current impulse, alternating current and/or
DC current.Further include the current measuring unit of such as ammeter by the circuit that processor is connected to electrode, allows to pass through
The measurement of the voltage and current of function as the time is by processor computing impedance.Processor include for the time measurement when
Clock, and memory is connected to allow to record sensing data, and the instruction comprising to be executed by processor.Optionally,
Processor is also connected to transmitting set, allows to send external receiver for the data of record to be used to be set by outside calculating
It is standby to be handled.External receiver can be such as mobile device or WiFi antenna, and receiver and transmitter can be used
The communication protocol appropriate of such as bluetooth, honeycomb, WiFi or other agreements is communicated.Figure 50 C provides such as Figure 50 A institute
The more details of the internal structure of the utensil shown.
Figure 50 B shows the wearable utensil 5010 on patient teeth 5012 comprising positions each other very closely
Sensor.The utensil includes utensil shell 5014, and sensor includes multiple electrodes 5016 very close each other.For example,
It, may be very close when the shortest distance between the sensor of such as electrode is smaller compared with the width of respiratory tract.With more
The sensor separated at a distance is compared, and very close sensor can be more sensitive near field measurement.Electrode is configured as when trouble
Intraoral multiple points 5018 nearby of patient are contacted when person's worn appliance.In this illustration, contact point is located at cheek side gum
On；In other embodiments, contact point can on cheek or lip, or contact tongue and tongue side gum tongue side
On.Contact point can also contact the tooth on tongue and/or cheek side (including a sensor on the every side of tooth).Close electricity
Extremely the near field of impedance is changed sensitive；Therefore, they can be used for measuring in such as mouth as caused by saliva amount or changes of contents
The characteristic of impedance.For example, saliva between electrode 5016 and surrounding point 5018 is measured will if the oral area of patient becomes drier
It reduces, this can cannot be used to carry electric current and increase impedance due to saliva.Similarly, change (such as, the pH of saliva contents
Variation) it can for example be measured by the synthesis variation of its saliva electric conductivity.These characteristics can also have near field by providing
It is measured in conjunction with far-field measurement with the utensil of far field electrode configuration, such as by that field electrodes will add shown in such as Figure 50 B
It is added to the utensil of the far field electrode with such as Figure 50 A.Each electrode is to can be separately connected to processor and by processor
Control, or can be controlled by individual processor.
Figure 50 C shows the inside of the utensil 430 with embedded measurement system comprising control electronic device and sensing
Device.Utensil 430 includes the oral appliance layer 431 and 432 around control electronic device 433.It includes all for controlling electronic device 433
As battery power supply, generate and be used for the driving electronic device of faradic voltage pulse, and for measuring as the time
Then the measurement electronic device of memory is recorded in the data of generation by the electric current and voltage of function.Electronic device 433 is controlled to wrap
Processor and memory are included, which includes instruction, when executed, makes processor according to method disclosed herein control
System drives and measures electronic device to generate electric pulse and execute the measurement of such as impedance measurement.It controls electronic device and utilizes electric wire
434 are electrically coupled to one or more sensors, such as electrode 436 and 438.Electric wire 434 is preferably provided in the layer of utensil shell
It is interior, but may include the open connection between shell (for example, with reference to Figure 50 E).Electrode be configured to when utensil is worn with
The surface in the oral cavity of patient contacts.Electrode executes electric current generation and electric measurement under the guidance of control electronic device.Figure 50 C institute
The basic schematic diagram layout shown can be according to the various utensils for including configuration shown in Figure 50 A, Figure 50 B and Figure 50 D- Figure 50 G
In any in shell configuration, with electrode, driving electronic device and measure electronic device position on suitably variation carry out
It uses.
Figure 50 D shows the example of the expanding location of the substitution of the sensor for such as electrode and driving electronic device.
The configuration of utensil shell and electrode as shown in Figure 50 A, Figure 50 B and Figure 50 E- Figure 50 G can according to need change will drive
Alternative site is placed in measurement electronic device and electrode.For example, Figure 50 D shows the equipment with such certain modifications
440.The driving electronic device 441 of utensil 440 is located at the outside of shell, and additional oral cavity measuring device is allowed to be connected.For example,
Lead 442 may be coupled to external equipment while patient sleeps, allow utensil to record impedance and other data, without interior
Portion's power supply.Electrode can be located at from the tab (tab) 443 that the gingival edge of utensil extends, or even on such as electrode
In 444 flexible wired connection.For example, electrode 444 can be attached to the oral area of patient utensil on opposite sides or dentistry it is attached
Part, such as utensil 440.This allows to have greater flexibility in electrode configuration, with various for executing in the oral cavity of patient
Measurement.Tab 443 can be has preloading tab of the electrode to allow to be kept in contact on an internal surface.Such as the one of utensil 440
Shown in partial viewgraph of cross-section 445, when utensil is worn, tab 443 is configured in first far from denture and gums
Elastic bending between configuration 446 and the second configuration 447 that electrode is pressed on the gums of patient.Tab 443 is configured to apply
Add the inward force of preloading tab to be maintained in the second configuration 447, to keep the electricity between electrode and the gums of patient
Contact.Such electrode position is useful for example in the impedance of periodontal ligament (PDL) and the measurement of other electrical characteristics.
Figure 50 E shows the utensil of the lower casing of the lower teeth including the upper casing and suitable patient that are suitble to the upper teeth of patient,
Each shell includes the sensor of such as electrode.Utensil 450 include comprising top electrode 453 upper casing 451 and comprising lower electrode 454
Lower casing 452.For example, each electrode is located on the protruding portion of mandibular protraction equipment, with the situation for treating such as OSA, and
And protruding portion is configured to contact when each utensil is worn on the corresponding upper teeth and lower teeth of patient, to stretch out
Lower jaw.Interface 455 between protruding portion may include the conductive surface on each protruding portion, so that protruding portion forms electricity and connects
Touching allows each electrode to be controlled by the processor in one of two shells.It should be appreciated that electrode 453 and 454 does not need to be located at protruding portion
On, but the other positions (for example, on opposite side of patient's oral area) that can be located on their own shell.In such case
Under, electric wire can be provided in shell electrode, processor and interface 455 to link together.
Figure 50 F shows the utensil for being configured with the electrode on opposite sides in utensil shell to measure physiological property.
Utensil 460 includes the utensil shell 462 having on the opposite side of shell there are two electrode 464 and 466.Resistance can be measured between the electrodes
Anti- 468, as shown in Figure 50 F in the form of partial circuit diagram.Utensil shell 462 includes control electronic device comprising for example such as
Processor shown in Figure 50 C and memory.Processor determines the impedance Z between electrode, is then used to determine the one of patient
A or more physiological characteristic；For example, respiratory tract sectional area.
Figure 50 G shows the utensil 470 with the respective sensor on upper casing and lower casing, wherein the electronic system of sensor
Inductively couple.Utensil 470 includes the upper casing 471 with sensor 472 and the lower casing 472 with sensor 474.Two shells are every
A includes respective control electronic device, including respective processor, power supply and measurement and driving electronic device.Two shells are not
It is configured to be formed direct electrical contact；On the contrary, the electronic device of upper casing and lower casing inductively couples, so that each in response to from another
The transient state electric pulse of one transmitting.The sensor of Figure 50 G may be configured with as a sensor of transmitter and as receiver
A sensor；It is, for example, possible to use acoustic transmitters and receiver.In this way it is possible to execute and come in each shell
Toward the power path in the relevant measurement of signal of sensor, without connecting upper casing and lower casing electronic device.
If wherein sensor is located at isolated upper and lower part utensil shell, two shells can be coupled in various ways with reality
Existing coordinated measurement.For example, conductive coupling can be realized in various ways.Wired connection can be carried out between opposite dental arch.
In some embodiments, single monoblock type utensil can be more practical than the utensil for two dental arch.However, in acceptable interval
In the case where sensing, Elecrical connector can be placed on known contact point, such as shown in Figure 50 E.Another in coupling shows
It can include the conductive hinge bar of such as Herbst type bar between shell to provide conductive path in example.It is direct-coupled other
Method includes stretchable conductor, can work as between hook appropriate or button such as correction elastomer or patient
Implantation electric wire (subcutaneous line in such as cheek or the cementing line being attached on the inner surface in oral cavity) in oral area.
Figure 51 A shows the block diagram of the signal chains 5100 for carrying out impedance measurement using utensil disclosed herein.Driving
Electric current 5110 is supplied to electrode by electronic device, and characterized by carrier frequency Fc.In order to eliminate DC electric current, electric current transmission electrode
It is shielded by the high-pass filter of 5120 form of capacitor from current source.Electrode contacts the oral cavity of patient, provides and corresponds to electricity
The modulation 530 of the low frequency of impedance variations.The impedance can be modeled as baseline impedance RB plus variable impedance Δ R.Modulation be due to
Caused by the variation of Δ R, for example, when as patient respiratory caused by the variation of respiratory tract sectional area.Modulated signal is in receiving electrode
Place is received, and is also shielded by the high-pass filter of 540 form of capacitor.Then received signal passes through gain stage 550 and amplifies.
Hereafter, signal is synchronized demodulation 560 to remove carrier frequency Fc.Remaining high fdrequency component is removed with low-pass filter 570, is generated
The final signal to be measured.Then, analog-digital converter 580 converts the signal into digital signal, the digital signal by processor into
Row processing, the processor is by the computer-readable medium of obtained measurement data record to non-transitory.
When the signal chains 51A disclosed in Figure 51 A is applied to the physiological characteristic in monitoring patient's oral area, it is important that use
It does not stimulate or the signal frequency and amplitude of patient harm.For carrying out inductance measurement using electrode, the safe range of electric current may
In about 100 μ A or lower.It can choose the carrier frequency for modulated signal, suitably to minimize noise；For example, about
The carrier frequency of 10kHz is useful for many applications.Signal chains disclosed in Figure 51 A can be applied to using except electrode it
The system of outer sensor replaces above-mentioned electricity with such as energy converter, piezo-electric crystal or actuator/accelerometer pair proper sensors
Pole.Impedance modulation will be replaced correspondingly with the modulation of the particular sensor signal sensitive to its.It is for apply mechanical energy
System, can remain less than about 1N for the mechanical energy that continuous force is applied.For the transient force of such as cyclic force, can apply larger
Power；It is measured for example, about 5N or smaller amplitude can be applied for transient force.
Figure 51 B shows the multiple electrodes of the impedance of the system including oral cavity or respiratory tract for measuring such as patient
The schematic diagram of oral appliance.Alternating current is supplied to first electrode lead 525 by power supply 515.Contact conductor 525 can with to
The system 535 (oral cavity of such as patient) of measurement contacts.Voltage drop between lead 525 and lead 545 is with Ohm's law (V=
I*Z) approximate impedance of the mode based on system 535 and change；Therefore, it is possible to use voltage drop between electrode 525 and 545 with
Relationship between electric current determines the impedance of system 535.Each of conventional method measurement voltage and current, example can be used
Such as use voltmeter and/or ammeter.It may include pullup or pulldown resistor 555 to ensure that it is suitable that the electric signal of input has
When voltage reference.Then the input AC signal from contact conductor 545 is demodulated at signal conditioner 565, wherein according to need
Apply gain with amplified signal.Remaining high frequency element is removed with low-pass filter, and memory then is recorded in the signal
575 for analyzing.As data are accumulated at any time, the device for processing of datagram 585 point of impedance vs time can be generated
Analysis.Data can also be sent to such as for example showing and for example by the outside of the mobile device of medical professional's analysis
Equipment.
Figure 52 shows for using utensil in mouth disclosed herein the method 5200 for monitoring the physiological characteristic of patient.
In step 610, utensil is located in the mouth of patient.Utensil may include such as utensil shell, or even more than
Utensil shell, such as those disclosed herein utensil shell.The utensil includes the multiple electrodes being arranged in one or more shells, and
And be configured as when patient wear mouth in utensil when and patient oral cavity be in electrical contact.
In step 620, impedance measurement is executed by being coupled to the processor of electrode.Impedance measurement can be for example using all
It is executed such as the signal chains of signal chains 500.The impedance due to caused by the physiological change (variation of such as respiratory tract obst ruction) of patient
Variation lead to the modulation of current signal.After the carrier frequency to current signal is amplified and demodulated, remaining signal can
To be sent through low-pass filter to obtain analog signal.The variation of the signal corresponds to the variation of impedance.Analog-digital converter
Can be generated the sequence by the readable signal data of processor as the signal value changed over time, and the sequence include can be with
Determine the information of impedance variations.For example, can be determined by being changed with frequency detected signal substantially similar with respiratory rate
The impedance variations caused by breathing.
In act 630, the data for corresponding to impedance measurement are recorded in memory processor.Optionally, processor
Transmitter can be made to transmit data to remote receiver in the memory that is recorded in outside utensil.For example, mobile device
Or other calculating equipment can be used wired or wireless technology (for example, bluetooth, WiFi or cellular communication) and be led to processor
Letter.
In step 640, physiological characteristic is determined based on the impedance measurement data being recorded in memory.For example, physiology
It is living that feature can be crowded respiratory tract diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level, soft tissue, respiratory rate, muscle
The ion composition of dynamic, saliva ion composition or oral mucosa, or combinations thereof.Respiratory tract diameter, volume and resistance can pass through
Measurement is determined by the variation of the far field impedance of electrode measurement.These size variations may be used as the crowded index of soft tissue.Example
It such as, can be by detecting impedance variations relevant to patient respiratory come isolation signals.Respiratory rate can be by seconds
The slow cyclically-varying of time cycle detection overall impedance determine.The spy for the current impulse that can be returned by measurement
Property, especially its delay time and phase determine lung liquid level.Muscle activity, the ion composition of saliva or the ion of oral mucosa
Composition can be measured with field electrodes；From the electrical impedance that molecular variation changes intervention fluid, and muscle activity generation can
With the electric current of electrode detection.
Figure 53 is shown using the transmitter-receiver being arranged in mouth in utensil to come the oral cavity or the breathing that monitor patient
The method 5300 of the feature in road.
In step 5310, utensil is located in the oral area of patient.Utensil may include such as utensil shell, or even more
A utensil shell, such as those disclosed herein utensil shell.The utensil include the transmitter that is arranged in one or more shells and
Receiver.For example, transmitter and receiver can replace the electrode in utensil substantially as described in Figure 50 A- Figure 50 F
To place.Transmitter and receiver also can be set in a pair of of shell with inductive coupling electronic device, as shown in Figure 50 G.
In step 5320, transmitter sends signal in oral cavity.The example of transmitter and corresponding transmitting signal includes hair
The electrode of radio pulse, the energy converter for transmitting sound wave and the actuator for transmitting mechanical force.
In step 5330, response signal is received and is handled by processor, and memory is then recorded.For example, response
Signal can be generated by the interaction between the oral cavity of signal and patient and/or the part of respiratory tract transmitted, such as be organized
Or scattering, reflection or the stimulation of fluid.Response signal is received by receiving sensor.Receiving sensor and correspondingly received signal show
Example includes the electrode for receiving piezoelectric pulses, receives the energy converter of reflected acoustic wave and detect the accelerometer of acceleration.Institute is received
Signal includes the information about its tissue and/or fluid that are advanced through, can be analyzed to determine physiological characteristic；For example, connecing
The modulation of the amplitude, frequency and phase of the collection of letters number can correspond to the mutually strain in the oral cavity of patient or the transmission medium of respiratory tract
Change.
In step 5340, physiological characteristic is determined based on the sensor measurement data being recorded in memory.Determining
Physiological characteristic can be the compression reaction of such as bone and collagen；Remporomandibular joint occlusion；It grinds one's teeth in sleep or tightly grits one's teeth；Upper respiratory tract flesh
Meat activity decline；The rigidity of tooth-PDL structure；Tooth, root of the tooth and/or PDL health；Voice response based on surrounding tissue
Root structures；Oral cavity or upper respiratory tract shapes and sizes；Soft tissue is crowded；The opening of oral area is closed；Lower jaw stretch out or after
It moves.These physiological characteristics can be determined using above-mentioned sensor and physiological relation appropriate about Figure 50 A- Figure 50 G respectively.
Figure 54 shows the method that manufacture includes the utensil of sensor and control electronic device 5400.
In step 5410, the dental structure of patient is obtained.The structure can be the form of physical mask or model, or
Such as the 3D rendering of patient's denture.
In step 5420, the first layer of appliance material is deposited.The deposition can be for example applies thermoforming on mold
Plastic layer.Optionally, material can be deposited by directly manufacturing, such as using 3D printer, according in step 5410
3D rendering based on patient's denture and generate for install patient teeth utensil 3D model.In some embodiments, it walks
Rapid 5420 and 5440 can be combined into single step, wherein directly making around the control electronic device and sensor of step 5430
Make utensil shell.
It, will control electronic device and sensor is in place is placed on the first layer of utensil in step 5430.Root
Each component of sensing system is connected according to needing to provide wiring.In this step, carbon fiber can be integrated in rectifier
To generate the antenna for carrying out wireless communication with external receiver.Multiple electrodes or other sensors can be provided to enhance letter
Number acquisition；For example, in a manner of being similar to the nerve electrode for eeg measurement.
In step 5440, such as in step 5420, the second layer of appliance material is deposited.The second layer in conjunction with first layer
Surround control electronic device and sensor.
In step 5450, if it is desired, any material of covering sensor lead can be removed.It is, for example, possible to use
Robotic milling or laser cutting machine remove the appliance material of covering electrode, energy converter, actuator, accelerometer etc., so as to
It provides when utensil is worn and is contacted with the clear of the appropriate part of patient's oral area.
In order to preferably separate signal relevant to the physiological characteristic to be measured, sensor fusion techniques can be used and carry out group
Close multiple sensing systems.For example, as described above, respiratory tract change width is related to patient respiratory.Patient respiratory frequency can be with
It is determined using the accelerometer being located in mouth in utensil.Figure 55 A-55C shows the gyro with the maxilla for being coupled to patient
The exemplary rotary speed data that instrument accelerometer is collected.Grey chromatography is shown loosely is coupled to body near hip joint
The rotary speed data of sensor.Black spectrum shows the respective counts from the sensor for being coupled to patients jaw via utensil
According to.The spectrum on the left side shows the initial data in each of dimension of x, y and z, and the spectrum on the right then shows and is converted into Fu
Vertical vane space and the identical data for being shown as power spectrum.The power spectrum of the black curve of measurement jaw portion movement shows that maximum value is omited
Respiratory rate lower than 1Hz, corresponding to patient.In contrast, the measurement at patient's hip joint only shows weak signal.Therefore, mouth
Interior measurement can be used for measuring the signal to patient respiratory frequency sensitive.Using the respiratory rate of the measurement, can have by detection
There are the impedance variations of substantially matched frequency influence of the respiratory tract change width to the impedance measurement for carrying out self-electrode is isolated.Due to
Impedance measurement is also sensitive to the breathing of patient, therefore impedance and acceleration signal can be measured and be intersected by utensil in mouth and tested
Card is to provide the respiratory rate measurement result with more high accuracy.
In some embodiments, the utensil including sensor disclosed herein can be therapeutic appliance, such as orthodontic appliance
Or the utensil for treating sleep apnea.In this utensil, the monitoring to physiological condition may include therapeutic effect
Assessment.It is, for example, possible to use utensils in mouth to treat sleep apnea, and is become by the synthesis of tracking respiratory tract diameter or volume
Change to monitor validity.The teeth training due to caused by orthodontic force can also be measured, correction is such as applied by utensil by monitoring
The rigidity of the tooth-PDL structure of power.
Utensil (such as those disclosed herein) with tooth receiving cavity includes for example applying via due to utensil elasticity
The power added receives and the utensil of repositioning teeth.The example of such utensil generally relates to Figure 1A and shows.Figure 1A is shown can
Utensil or rectifier 1000 are relocated with the Representative dental worn by patient, to realize each tooth 1002 in jaw portion
It is incremented by and relocates.The utensil may include having reception and the flexibly shell of the tooth receiving cavity of repositioning teeth.It can be with
Utensil or part thereof is manufactured indirectly using the physical model of tooth.It is, for example, possible to use the physical model of tooth and suitably
The thin slice of polymer material layer forms utensil (for example, polymer utensil).In some embodiments, physical devices are according to utensil
Mathematical model for example directly manufactured using RP technique.
It while reference has been made to include the utensil of polymer shell-type utensil, but embodiment disclosed herein is highly suitable for receiving
Many utensils of tooth use, such as one or more of utensils without polymer or shell.For example, the utensil can be used
Such as many of metal, glass, reinforcing fiber, carbon fiber, composite material, enhancing composite material, aluminium, biomaterial and combinations thereof
One of material or more is made.For example, the utensil can shape in many ways, such as made using thermoforming or directly
Make (for example, 3D printing, addition manufacture).Optionally or in combination, it can use machining manufacture utensil, such as with calculating
Machine is digital control to process the utensil manufactured by material block.
Utensil may be mounted on all teeth present in the upper jaw or lower jaw or less than all teeth.The utensil can be with
It is specially designed for accommodating the tooth of patient (for example, the topological structure of the topological structure of tooth receiving cavity and patient teeth
With), and can be manufactured based on the positive or negative model of the patient teeth by generations such as stamp, scannings.Optionally, which can
To be configured as receiving the general utensil of tooth but different figuration to match the topological structure of patient teeth.In certain situations
Under, the certain teeth only received by utensil will be relocated by utensil, and other teeth can be provided for fixing utensil
Base portion or anchorage zone in place, because it is to for the tooth or multiple teeth applied force relocated.Some
In embodiment, certain moment during treatment, some, most of or even whole teeth will be relocated.It is moved
Tooth be also used as base portion or anchoring piece for the fixed appliance when it is worn by the patient.It is used in general, will not provide
Utensil is fixed on the steel wire of appropriate location or other devices on tooth.In some situations, however, it may be desirable to or need
Individual attachment or other anchoring elements 1004 are provided on tooth 1002, wherein there is in utensil 1000 corresponding recipient or hole
1006, allow utensil to apply selected power to tooth.IncludingExemplary appliance used in system by
It gives in many patents and patent applications of Align Technology company and is described, including such as U.S. Patent No. 6,450,
No. 807 and No. 5,975,893 and public affairs (see, for example, URL " invisalign.com ") can be accessed on the world wide web (www
Take charge of website.The example of attachment suitable for the tooth installation being used together with orthodontic appliance is also being assigned to Align
It is described in the patents and patent applications of Technology company, including such as U.S. Patent No. 6,309,215 and the 6th, 830,
No. 450.
Figure 1B shows the tooth including multiple utensils 1012,1014,1016 and relocates system 1010.It is described herein
Any one of utensil can be designed and/or be provided as one group of multiple utensil used in tooth repositioning system
A part.Each utensil may be configured so that tooth receiving cavity with corresponding to the centre for being intended for the utensil or most
The geometry of whole teeth arrangement.The tooth of patient can be by placing a series of incremental positions adjusters on the tooth of patient
Tool is incremented by from initial teeth arrangement and is repositioned onto target tooth arrangement.For example, tooth repositioning system 1010 may include
Corresponding to the first utensil 1012 of initial teeth arrangement, corresponding to one or more centres of one or more intermediate arrangements
Utensil 1014 and final utensil 1016 corresponding to target array.Target tooth arrangement can be in the planned orthodontic treatment of institute
At the end of for patient tooth select plan final teeth arrangement.Optionally, target array can be in orthodontic treatment mistake
It may include a variety of different therapeutic schemes for one of some intermediate arrangements of patient teeth during journey, including but unlimited
In wherein recommend operation the case where, it is wherein adjacent between reduce the case where (IPR) is appropriate situation, wherein arranges follow-up, its
The best situation of middle anchorage point wherein needs the case where carrying out palate expansion, is directed to prosthetic dentistry (for example, inlaying, pasting
Piece, hat, bridge, implantation material, veneer etc.) the case where etc..It will thus be appreciated that target tooth arrangement can be and follow one or more
The result of any plan of the patient teeth in multiple incremental repositioning stages arranges.Similarly, initial teeth arrangement can be
It is one or more incremental repositioning stages behind for any initial arrangement of patient teeth.
The various embodiments of orthodontic appliance proposed in this paper can manufacture in a wide variety of ways.As an example, can be with
Such as produced by the thermoforming on formpiston or former using indirect fabrication technology this paper utensil (or part thereof) it is some
Embodiment.The indirect fabrication of orthodontic appliance may include generating patient with target array (for example, by rapid shaping, milling etc.)
The formpiston or former of denture, and one or more material sheets of thermoforming on mold, to generate utensil shell.Optionally or
In combination, some embodiments of the utensil of this paper can be manufactured directly, such as use rapid shaping, stereolithography, 3D printing
Deng.
The configuration of the orthodontic appliance of this paper can be determined according to the treatment plan of patient, for example, being related to continuous administration use
In the treatment plan for the multiple utensils for being incremented by repositioning teeth.Computer based treatment plan and/or utensil can be used
Manufacturing method promotes designing and manufacturing for utensil.For example, one or more instrument assemblies described herein can be by
In the manufacturing equipment that computer controls (for example, (such as 3D is beaten the rapid shaping of computer numerical control (CNC) milling, computer control
Print etc.)) carry out Digital Design and manufacture).Computer based method proposed in this paper can be improved utensil manufacture accuracy,
Flexibility and convenience.
In some embodiments, orthodontic appliance (utensil such as shown in figure 1A) is in the tooth receiving cavity of utensil and received
At one or more contact points between tooth and/or attachment, exert a force to the tooth on tooth bizet and/or
Attachment.Orthodontic tooth caused by the size of each of these power and/or its distribution on tooth surfaces can determine moves
Dynamic type.Tooth movement can be in any direction in any plane in space, and may include along one or more
The rotation of multiple axis is one or more in translation.As discussed further herein, the mobile type of tooth includes
It squeezes, invade, rotating, tumbling, translating and root is mobile and combinations thereof.The mobile movement for being greater than root of the tooth of the tooth of corona can claim
To tumble.The equivalent movement of corona and root of the tooth is properly termed as translating.The movement that root of the tooth is greater than corona is properly termed as root of the tooth movement.
When feature or element are when being described herein as " in another feature or element ", it can directly in other features or
On element, or it is also likely to be present intermediate feature or element.On the contrary, when feature or element are described as " directly existing " another feature
Or when element "upper", intermediate feature or element do not exist.It should be appreciated that when feature or element be described as " connecting ", " attached
Connect " or when " coupled " to another feature or element, it can be directly connected to, be attached or coupled to other features or element, or can deposit
In intermediate feature or element.On the contrary, when feature or element referred to as " being directly connected to ", " directly attachment " or " direct-coupling " arrive
When another feature or element, intermediate feature or element do not exist.Although being described or showing relative to one embodiment
Out, the feature and element for but describing or showing in this way can be applied to other embodiments.It would be recognized by those skilled in the art that
The structure or feature for mentioning the setting of " neighbouring " another feature can have part Chong Die with adjacent feature or below adjacent feature.
Terms used herein are used only for the purpose of describing specific embodiments, and are not intended to be limited to the disclosure.For example, removing
Except context clearly states, as used herein, singular " a (one) ", " an (one) " and " the (described) " is intended to equally
Including plural form.It will be further understood that term " including (comprises) " and/or " including (comprising) " when
In use, specifying stated feature, step, operation, the presence of element and/or component in this specification, but do not exclude the presence of
Or one or more other features of addition, step, operation, element, component and/or their group.As used herein, term
"and/or" includes any combination and all combinations in one or more of associated listed items, and can be abbreviated as
“/”。
The term of space correlation, such as " ... under (under) ", " ... under (below) ", " be lower than (lower) ",
" ... upper (over) ", " top (upper) " etc. can be used herein, in order to describe an element as shown in drawings
Or feature is to another elements or features or the relationship of multiple element or feature.It will be appreciated that the opposite term in space is intended to
Different orientation including the device in the use or operation other than the orientation described in attached drawing.For example, if in attached drawing
Equipment is reversed, and is described as " (under) under other elements or features ", " (beneath) under other elements or features "
Element will then will be oriented " (over) in other elements or features ".Therefore, exemplary term " ... under
(under) " can cover ... and ... under two kinds of directions.The device, which can be additionally orientated, (to be rotated by 90 ° or at it
His orientation), and space relative descriptors used herein are interpreted accordingly.Similarly, in addition to other illustrate, art
Language " upward (upwardly) ", " downward (downwardly) ", " vertical (vertical) ", " horizontal (horizontal) " etc.
It is for the purpose of illustration herein.
Although term " first " and " second " can be used for describing various feature/elements (including step) herein,
It is that these feature/elements should not be limited by these terms, unless otherwise indicated by context.These terms can be used for one
A components/elements are distinguished with another components/elements.Therefore, it in the case where not departing from the introduction of the disclosure, is discussed below
Fisrt feature/element can be referred to as second feature/element, and similarly, second feature/element discussed below can be with
Referred to as fisrt feature/element.
In this specification and in the appended claims, unless the context otherwise requires, word " comprising ", and such as
The version of " comprising " and " comprising " mean can be used in conjunction in method and product various components (such as composition with
And the device including device and method).For example, term " includes " will be understood as implying comprising any element or step,
But it is not excluded for any other element or step.
In general, any device and method described herein should be understood inclusiveness, but component and/or step
All or subset can be optionally exclusive, and can be expressed as " consist of " or " composition " is substantially various groups
Part, step, sub-component or sub-step.
As used in the specification and in the claims herein, it is included in used in embodiment, unless otherwise clear
Illustrate, all numbers can be read as being started with word " about (about) " or " about (approximately) ", even if should
Term does not occur clearly.When description amplitude and/or position are to indicate described value and/or position in value and/or position
When within the scope of rational expectation, phrase "about" or "approximately" can be used.For example, numerical value can have as setting value (or the model of value
Enclose) +/- 0.1%, +/- the 1% of setting value (or range of value), +/- the 2% of setting value (or range of value), setting value
The range of value (or) +/- 5%, +/- 10% value of setting value (or range of value) etc..Any numerical value given in this article is answered
It is understood to include the about value or the about value, unless otherwise indicated by context.For example, if disclosing value " 10 ", it is also public
" about 10 " are opened.Any numberical range as described herein is intended to include all subranges being included in.It should also be understood that
It is as those skilled in the art suitably understand, when value is disclosed as " being less than or equal to " value, " to be greater than or wait
In the value " and value between possible range be also disclosed.For example, if value " X " is disclosed, " being less than or equal to X " and
" being greater than or equal to X " (for example, wherein X is numerical value) is also disclosed.It is also understood that in entire application, with a variety of not appositions
Formula provides data, and the data indicate any combination of end point and starting point and range for data point.For example,
If disclosing particular data point " 10 " and particular data point " 15 ", it should be appreciated that being greater than, being greater than or equal to, be less than, being less than
Or it is equal to and is considered equal to 10 and 15 and is equally disclosed between 10 to 15.It is also understood that also disclosing two spies
Each unit between order member.For example, also disclosing 11,12,13 and 14 if disclosing 10 and 15.
Although not departing from the disclosure as described in claims described above is various illustrative embodimentss
In the case where range, any of several changes can be carried out to various embodiments.For example, in an alternative embodiment, usually
It can change the sequence for executing various described method and steps, and in other alternative embodiments, one can be skipped together
A or more method and step.The optional feature of various equipment and system embodiment can be included in some embodiments without
It is included in other embodiments.Therefore, the description of front is mainly provided for exemplary purpose, and is not necessarily to be construed as
The scope of the present disclosure that limitation such as illustrates in the claims.
Example included by this paper and explanation are shown by way of illustration and not limitation wherein can be with the tool of practical matter
Body embodiment.As mentioned, can use and be derived from other embodiments, allow to make structure and logic replacement and
Change without departing from the scope of the present disclosure.Only for convenient, such embodiment of open Sexual Themes herein can be individually
Or jointly referred to by term " disclosure ", and be not intended to scope of the present application is initiatively limited to any single disclosure or
Public concept, if actually it is more than one be disclosed if.Therefore, although particular implementation has been illustrated and described
Example, but be designed to realize any arrangement of identical purpose can substitute shown in specific embodiment.The disclosure is intended to cover
Any and all modifications or modification of various embodiments.After reading above description, it will be appreciated by those skilled in the art that more than
The combination and this paper other embodiments not specifically described of embodiment.
Claims (51)
1. a kind of for monitoring the device of the physiological characteristic of patient, described device includes:
Utensil in mouthful, utensil is shaped to receive the tooth of patient and including multiple electrodes, each electrode positioning in the mouth
It is in electrical contact at when utensil is worn by the patient in the mouth with the oral cavity of patient；With
One or more processors, one or more processor are configured as:
Electrical impedance is measured using the multiple electrode, and
The physiological characteristic is determined based on the electrical impedance.
2. the apparatus according to claim 1, wherein the physiological characteristic includes one of the following or more: breathing
Road diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level, soft tissue be crowded, respiratory rate, muscle activity, the ion group of saliva
At or oral mucosa ion composition.
3. the apparatus according to claim 1, wherein the physiological characteristic is related to the sleep disturbance of patient, the sleep
Obstacle includes one of sleep apnea, snoring or bruxism or more.
4. device according to claim 3, wherein the sleep disturbance includes sleep apnea.
5. device according to claim 4, wherein utensil is configured as treating the sleep apnea in the mouth,
One or more processor is additionally configured to be assessed utensil in the mouth based on identified physiological characteristic and treated
The effect when sleep apnea.
6. device according to claim 4, wherein utensil is configured as monitoring sleep apnea in the mouth.
7. the apparatus according to claim 1, wherein the electrical impedance includes near field impedance, and the physiological characteristic packet
Include one of ion composition of crowded soft tissue, ion of saliva composition or oral mucosa or more.
8. the apparatus according to claim 1, wherein the electrical impedance includes far field impedance, and the physiological characteristic packet
It includes one or more in lung liquid level or respiratory tract length.
9. the apparatus according to claim 1, wherein one or more processor be configured as by response to from
Electric signal measurement waveform that electrode in the multiple electrode is sent measures the electrical impedance.
10. the apparatus according to claim 1, wherein the multiple electrode includes when patient wears utensil in the mouth
First electrode near on the left of the oral cavity of patient and the second electrode near the right side of the oral cavity of patient.
11. the apparatus according to claim 1, wherein the multiple electrode includes when patient wears utensil in the mouth
Supramaxillary first electrode positioned at patient and the epimandibular second electrode positioned at patient.
12. device according to claim 11, wherein utensil includes the tooth for being shaped to receive the upper jaw in the mouth
The first shell of tooth and be shaped to receive the second shell of the tooth of the lower jaw, and wherein the first electrode be coupled to it is described
First shell and the second electrode are coupled to the second shell.
13. the apparatus according to claim 1, wherein utensil is arranged in the mouth in one or more processor
It goes up or in the mouth in utensil.
14. the apparatus according to claim 1, wherein utensil includes the polymerization with multiple tooth receiving cavities in the mouth
Object shell.
15. a kind of for monitoring the device of the physiological characteristic of the respiratory tract of patient, described device includes:
Utensil in mouthful, utensil is shaped to receive the tooth of patient and including multiple electrodes, each electrode positioning in the mouth
It is in electrical contact at when utensil is worn by the patient in the mouth with the oral cavity of patient；With
One or more processors, one or more processor are configured as:
Far field electrical impedance is measured using the multiple electrode, and
One of the following or more is determined based on the far field electrical impedance: respiratory tract diameter, respiratory tract volume, respiratory tract resistance
Power, lung liquid level and respiratory rate.
16. a kind of device of the feature in the oral cavity or respiratory tract for monitoring patient, described device include:
Utensil in mouthful, utensil is shaped to receive the tooth of patient and including transmitter and receiver in the mouth；And
One or more processors, one or more processor are configured as:
The transmitter is set to emit signal in the oral cavity of patient,
The signal that the signal in response to being emitted is returned from the oral cavity of patient or respiratory tract is measured using the receiver, and
The oral cavity of patient or the feature of respiratory tract are determined based on measured signal.
17. device according to claim 16, wherein the feature includes one of the following or more: respiratory tract
Diameter, respiratory tract volume, resistance of respiratory tract, lung liquid level, soft tissue be crowded, respiratory rate, muscle activity, saliva ion composition
Or the ion composition of oral mucosa.
18. device according to claim 16, wherein the feature is related with the sleep disturbance of patient, the sleep barrier
Hinder including one of sleep apnea, snoring or bruxism or more.
19. device according to claim 16, wherein the signal emitted includes electric energy, sound energy or mechanical energy.
20. device according to claim 19, wherein the signal emitted includes electric energy, and one or more
A processor is additionally configured to determine the oral cavity of patient or the electrical impedance of respiratory tract based on measured signal.
21. device according to claim 16, wherein the signal emitted includes first waveform, measured signal packet
The second waveform is included, and one or more processor is additionally configured to identify the first waveform and second waveform
Between variation.
22. device according to claim 16, wherein one or more processor is disposed in device in the mouth
On tool or in the mouth in utensil.
23. device according to claim 16, wherein utensil includes the polymerization with multiple tooth receiving cavities in the mouth
Object shell.
24. a kind of for monitoring the equipment of utensil in mouth used, the equipment includes:
One or more deflectable structures, one or more deflectable structure are formed together together with utensil in the mouth
Or it is coupled to utensil in the mouth, wherein when utensil is worn on the tooth of patient in the mouth, it is one or more
Deflectable structure is shaped as deflection；And
Sensor, the sensor are configurable to generate the sensor for indicating one or more deflection of deflectable structure
Data；And
Processor, the processor can be operatively coupled to the sensor and be configured as handling the sensor number
According to determine, whether utensil is being worn on the tooth of patient in the mouth.
25. equipment according to claim 24, wherein utensil includes utensil shell in the mouth, and the utensil shell includes more
A tooth receiving cavity.
26. equipment according to claim 25, wherein one or more deflectable structure is located at the multiple tooth
Near tooth receiving cavity in tooth receiving cavity, to be deflected outward when tooth is located in the tooth receiving cavity.
27. equipment according to claim 26, wherein one or more deflectable structure is formed in the tooth
In the wall of receiving cavity.
28. equipment according to claim 26, wherein one when tooth is located in the tooth receiving cavity
Or more deflectable structure be deflected outward at least 25 μm.
29. equipment according to claim 24, wherein one or more deflectable structure includes when in the mouth
Deflection state when utensil is worn and the stationary state when utensil is not worn in the mouth, and it is wherein one
Or more deflectable structure interact when being in the deflection state with the sensor.
30. equipment according to claim 29, wherein the sensor includes mechanical switch, and one or more
Multiple deflectable structures are engaged when being in the deflection state with the mechanical switch.
31. equipment according to claim 29, wherein the sensor includes optical switch, and one or more
Multiple deflectable structures activate the optical switch when being in the deflection state.
32. equipment according to claim 24, wherein one or more deflectable structure include cantilever, scrobicula,
Concave surface, fin, protruding portion or ejecting structure.
33. equipment according to claim 24 further includes communication unit, the communication unit can be operatively coupled to institute
Sensor is stated, and is configured as one or more transmissions in the sensing data or processed sensing data
To remote equipment.
34. equipment according to claim 24, wherein utensil is integrated or coupled to tooth in the sensor and the mouth
Tooth.
35. equipment according to claim 24, wherein utensil is integrated or coupled to tooth in the processor and the mouth
Tooth.
36. a kind of for monitoring the equipment of utensil in mouth used, the equipment includes:
Utensil shell, the utensil shell include multiple tooth receiving cavities；
One or more proximity sensors, one or more proximity sensor can be operatively coupled to the utensil
It shell and is configured as generating sensing data when close with mouth inner tissue；With
Processor, the processor can be operatively coupled to one or more proximity sensor and be configured as locating
The sensing data is managed, whether utensil is being worn on the tooth of patient in the mouth to determine.
37. equipment according to claim 36, wherein one or more proximity sensor includes one or more
A touch sensor.
38. the equipment according to claim 37, wherein one or more touch sensor includes at least one electricity
Appearance formula touch sensor, at least one described capacitive touch sensors by with enamel, gum, oral mucosa, saliva, face
One or more associated charge activation in cheek, lip or tongue；Or in which one or more touch sensing
Device includes one or more works being configured in enamel, gum, oral mucosa, saliva, cheek, lip or tongue
For at least one capacitive touch sensors of grounding electrode.
39. the equipment according to claim 37, wherein one or more touch sensor includes by with patient's
At least one capacitive touch sensors of the associated positive charge activation of patch or bacterium on tooth.
40. equipment according to claim 39, wherein the processor is configured to the sensing data is handled, with
Just the amount of the bacterium on the tooth of patient is determined.
41. the equipment according to claim 37, wherein one or more touch sensor includes at least one electricity
Resistive touch sensor.
42. equipment according to claim 36, wherein one or more proximity sensor includes one in following
A or more: capacitance type sensor, eddy current sensor, magnetic sensor, optical sensor, photoelectric sensor, ultrasonic wave pass
Sensor, hall effect sensor, Infra red touch sensors or surface acoustic wave SAW touch sensor.
43. equipment according to claim 36, wherein one or more proximity sensor is configured as when close
Sensing data are generated when one or more in the enamel of patient, gum, oral mucosa, cheek, lip or tongue.
44. equipment according to claim 36, wherein utensil in one or more proximity sensor and the mouth
Integrate, be coupled to tooth or combinations thereof.
45. equipment according to claim 36, wherein utensil is integrated or coupled to tooth in the processor and the mouth
Tooth.
46. a kind of for monitoring the equipment of utensil in mouth used, the equipment includes:
Utensil shell, the utensil shell include multiple tooth receiving cavities；
One or more vibrating sensors, one or more vibrating sensor can be operatively coupled to the utensil
Shell and it is configurable to generate a mouthful sensing data for internal vibration mode；And
Processor, the processor can be operatively coupled to one or more vibrating sensor and be configured as locating
The sensing data is managed, whether utensil is being worn on the tooth of patient in the mouth to determine.
47. equipment according to claim 46, wherein one or more vibrating sensor includes one in following
It is a or more: MEMS condenser microphone, accelerometer or piezoelectric transducer.
48. equipment according to claim 46, wherein the mouth internal vibration mode and one of the following or more phase
Association: the vibration of the tooth of patient is transmitted to via the jawbone of patient, is ground one's teeth in sleep, speech, chewing, breathing or snoring.
49. equipment according to claim 46, wherein the processor passes through the mouth internal vibration mode and patient is special
Fixed mouth internal vibration mode is compared to determine in the mouth whether utensil is worn.
50. equipment according to claim 46, wherein utensil in one or more vibrating sensor and the mouth
It integrates, be coupled to tooth, or combinations thereof.
51. equipment according to claim 46, wherein utensil is integrated or coupled to tooth in the processor and the mouth
Tooth.
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| US15/625,872 | 2017-06-16 | ||
| US15/625,872 US10470847B2 (en) | 2016-06-17 | 2017-06-16 | Intraoral appliances with sensing |
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| CN202310353407.1A Pending CN116350366A (en) | 2016-06-17 | 2017-06-19 | Intraoral appliance utilizing sensing |
| CN202110945246.6A Active CN113616362B (en) | 2016-06-17 | 2017-06-19 | Intraoral appliance with sensing |
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| CN202310353407.1A Pending CN116350366A (en) | 2016-06-17 | 2017-06-19 | Intraoral appliance utilizing sensing |
| CN202110945246.6A Active CN113616362B (en) | 2016-06-17 | 2017-06-19 | Intraoral appliance with sensing |
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| US (4) | US10470847B2 (en) |
| EP (1) | EP3471599A4 (en) |
| CN (3) | CN208447812U (en) |
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| EP3471599A1 (en) | 2019-04-24 |
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